No full-text available
To read the full-text of this research,
you can request a copy directly from the authors.
Novel method for analyzing Snellen visual acuity measurements
Abstract
Most retrospective reviews convert Snellen visual acuity measurements obtained during routine clinic visits to logarithm of the minimum angle of resolution (logMAR) units so that statistical manipulations can be performed. However, visual acuity measurements expressed as logMAR units are not intuitively interpretable by clinicians. A more intuitive approach is presented here which uses the conversion of Snellen visual acuity fractions to Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores for statistical manipulations.
Snellen visual acuity measurements were converted to approximate ETDRS (approxETDRS) letter scores for statistical manipulations and then converted back to Snellen equivalent fractions. The formula to convert Snellen visual acuity measurements to approxETDRS letter scores is 85 + 50 x log (Snellen fraction), which may be rounded to the nearest letter.
A linear relationship exists between true ETDRS letter scores, approxETDRS letter scores, and logMAR units. The interconversion between Snellen visual acuity measurements, logMAR units, and approxETDRS letter scores was prepared in a tabular form for easy reference. The same outcomes (in Snellen fractions) were obtained with statistical manipulation of either approxETDRS letter scores or logMAR conversions.
Conversion of Snellen visual acuity fractions to approxETDRS letter scores for the purpose of performing statistical manipulations provides more readily interpretable outcomes compared with the current strategy of converting Snellen visual acuity fractions to logMAR units.
... Visual acuity (VA) was a secondary endpoint. VA was scored by VH using an approximation of ETDRS measurement, according to the method of Gregori et al., by converting Snellen VA of 20/20, to 85 letters; 20/40 to 70 letters; 20/80 to 55 letters; 20/160 to 40 letters, etc. 25 . ...
... trial. However, while some variation is likely, such variations would be expected to be offset by the large sample size and PS matching of all conversion risk factors [25][26][27][28][29][30] . Propensity scoring is the gold-standard of statistical analysis for large pre-existing populations, typically the subject of real-world data studies such as the current study [26][27][28][29][30] . ...
To access the effect of vision protection therapy on neovascular conversion in age-related macular degeneration (AMD). Patient unidentified data aggregated by Vestrum Health, LLC (VH) from over 320 US retina specialists was analyzed to compare the conversion rate from dry to neovascular (wet) AMD in a practice employing VPT (VPT group) compared to those employing standard care alone (SCA group) between January 2017 through July 2023. 500,00 eyes were filtered then matched for neovascular conversion risk factors by propensity scoring and compared in a 10/1 ratio of 7370 SCA and 737 VPT treated eyes. SCA eyes had significantly fewer clinical encounters and shorter follow up than the VPT group. Despite this, the risk of neovascular conversion by PS was significantly lower in the VPT group compared to SCA (HR 5.73, p < 0.0001). Analysis matching the encounter frequency of both groups as a post-randomization variable produced a similar HR (HR 5.98, p < 0.0001). Because 9% of eyes in the VPT group were not treated with VPT due to bilateral early (low-risk) AMD, analysis comparing the SCA group to VPT-treated eyes was done that also showed significantly lower conversion rates in the VPT-treated eyes, with or without encounter frequency matching (HR 5.84, 5.65, p < 0.0001). Visual acuity was consistently better in VPT eyes compared to SCA eyes throughout the study time window. The advantage of VPT over SCA increased with increased SCA encounter frequency and higher conversion risk factors, including age and ICD10 coded dry AMD severity. Neovascular (wet) AMD is the main cause of irreversible visual loss worldwide. Consistent with two prior studies, the current study finds Vision Protection Therapy markedly more effective at both recognizing and preventing neovascular AMD than the current standard of care, benefiting the highest risk dry AMD eyes the most.
... In addition to treatment administration, a follow-up evaluation was performed at Weeks 4, 8, 24, 36, and 48 to assess safety, tolerability, BCVA changes, and physiologi-cal changes. The Early Treatment Diabetic Retinopathy Study (ETDRS) approximation, letters = 85 − (50 × logarithm of the minimum angle of resolution), was utilized to calculate BCVA, and the same type of VA measurement at each visit was ensured for consistency [8]. Slit lamp examination, intraocular pressure measurement, OCT, and fundus photography assessed anatomical changes and safety profiles during the study period. ...
Background/Objectives: The objective of this study was to determine the treatment effect of foselutoclax in neovascular age-related macular degeneration (AMD) by multifocal electroretinography (mfERG) and evaluate mfERG as a potential clinical endpoint in AMD studies. Methods: A total of five subjects were included in the study who had active choroidal neovascularization and a history of at least two anti-vascular endothelial growth factor (VEGF) injections in the last 6 months. Subjects received a 50 µL intravitreal injection of foselutoclax at the baseline visit and Weeks 4, 24, and 28 of the study period. Results: After foselutoclax treatment, the largest improvement in the mfERG N1-P1 response density occurred at Week 8 as three of five subjects achieved a ≥20% gain. In addition, three of five subjects demonstrated a BCVA improvement of ≥5 ETDRS letters over baseline at Weeks 4, 8, and 24. The mean change in BCVA demonstrated statistical significance in Weeks 4 and 8, showing increases of 5 (p = 0.02) and 6.2 (p = 0.02) letters, respectively. Conclusions: Foselutoclax treatment was shown to have the potential to recover outer retinal function as determined by mfERG and BCVA at approximately Week 8 of treatment.
... Hier werden der primäre Endpunkt sowie die 24-Monatsdaten der deutschen Kohorte behandlungsnaiver DMÖ-Patienten berichtet. Visuswerte wurden in ETDRS-Buchstaben umgerechnet [10]. ...
Zusammenfassung
Hintergrund
AURIGA ist die größte prospektive Real-world-Studie zur Behandlung des diabetischen Makulaödems (DMÖ) bzw. des Makulaödems nach retinalem Venenverschluss mit intravitrealem Aflibercept (IVT-AFL). Hier werden die 24-Monatsdaten der deutschen behandlungsnaiven DMÖ-Kohorte präsentiert.
Methoden
Behandlungsnaive DMÖ-Patienten wurden mit IVT-AFL in der klinischen Routine therapiert. Primärer Endpunkt war die mittlere Änderung des Visus (ETDRS-Buchstaben) zu Monat 12 gegenüber dem Ausgangswert. Die Analyse erfolgte deskriptiv.
Ergebnisse
Die Analyse umfasst Daten von 150 DMÖ-Patienten (54,7 % männlich). Zu Monat 6, 12 und 24 wurden im Mittel (95 %-Konfidenzintervall) Visusgewinne von 4,6 (2,6; 6,5), 4,0 (2,1; 6,5) und 5,0 (3,0; 6,9) Buchstaben im Vergleich zum Ausgangswert (Mittel ±SD: 65,0 ± 15,3 Buchstaben) sowie eine Reduktion der Netzhautdicke um 86 (109; 64) µm, 70 (94; 43) µm und 75 (103; 47) µm vom Ausgangswert (Mittel ±SD: 391 ± 132 µm) erreicht. Zu Monat 24 hatten 54 % der Patienten ≥ 5 Buchstaben gewonnen und 22 % ≥ 15 Buchstaben. Die mittlere Injektionszahl betrug 5,0 ± 1,6 bis Monat 6, 7,1 ± 3,2 bis Monat 12 und 9,0 ± 5,3 bis Monat 24. 68 % der DMÖ-Patienten erhielten ≥ 5 Injektionen bis Monat 6, 56 % ≥ 7 Injektionen im ersten Jahr. Das Sicherheitsprofil entsprach dem früherer AFL-Studien.
Diskussion
In der deutschen AURIGA-Kohorte behandlungsnaiver DMÖ-Patienten unter IVT-AFL-Behandlung im klinischen Alltag zeigten sich ein zügiger und klinisch relevanter Visusgewinn sowie eine Reduktion der zentralen Netzhautdicke. Beides wurden ab Monat 6 mit reduzierter Injektionsfrequenz über 24 Monate erhalten. Im Vergleich zu früheren Real-world-Studien deutet sich zwar eine verbesserte Versorgungsqualität von DMÖ-Patienten im klinischen Alltag an, dennoch besteht weiteres Optimierungspotenzial.
... The measurement of VA on the Snellen scale was converted to letters according to the formula proposed by Gregori et al. of the Early Treatment Diabetic Retinopathy Study (ETDRS). (16) This form of measurement was used because the data obtained are easier to analyze compared to the measurement of fractions on the Snellen scale. ...
... In RCTs, visual acuity (VA) was frequently quantified and reported as an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score. When the logarithm of the minimum angle of resolution (log-MAR) or Snellen chart scores were used to measure VA, the score was converted to approximate ETDRS letter scores using the method proposed by Gregori et al. [33], which was used in quantitative analysis. The secondary outcomes were as follows: 1) progression of cataract compared with baseline; and 2) any instance intraocular pressure (IOP) increase at any follow-up visit count compared to baseline IOP. ...
Objectives
To evaluate the clinical efficacy of dexamethasone (DEX) implant, for the treatment of macular edema (ME) caused by retinal vein occlusion (RVO) and diabetic retinopathy (DR) through a systematic review and meta-analysis.
Methods
The PubMed, Embase and Cochrane Library databases were comprehensively searched from inception to November 21, 2022, for studies evaluating the clinical efficacy of DEX implant for patients with retinal vein occlusion macular edema (RVO-ME) or diabetic macular edema (DME). Randomized controlled trials (RCTs) published in English were considered eligible. The Cochrane Collaboration tool was applied to assess the risk of bias in each study. Effect estimates with 95% confidence intervals (CIs) were pooled using the random effects model. We also conducted subgroup analyses to explore the sources of heterogeneity and the stability of the results.
Results
This meta-analysis included 8 RCTs (RVO-ME [n = 2] and DME [n = 6]) assessing a total of 336 eyes. Compared with anti-VEGF therapy, DEX implant treatment achieved superior outcomes in terms of best corrected visual acuity (BCVA) (mean difference [MD] = -3.68 ([95% CI, -6.11 to -1.25], P = 0.003), and no heterogeneity was observed (P = 0.43, I² = 0%). DEX implant treatment also significantly reduced central macular thickness (CMT) compared with anti-VEGF treatment (MD = -31.32 [95% CI, -57.92 to -4.72], P = 0.02), and there was a high level of heterogeneity between trials (P = 0.04, I² = 54%). In terms of severe adverse events, DEX implant treatment had a higher risk of elevated intraocular pressure than anti-VEGF therapy (RR = 6.98; 95% CI: 2.16 to 22.50; P = 0.001), and there was no significant difference in cataract progression between the two groups (RR = 1.83; 95% CI: 0.63 to 5.27, P = 0.31).
Conclusions
Compared with anti-VEGF therapy, DEX implant treatment is more effective in improving BCVA and reducing ME. Additionally, DEX implant treatment has a higher risk of elevated intraocular pressure. Due to the small number of studies and the short follow-up period, the results should be interpreted with caution. The long-term effects of the two treatments need to be further determined.
Trial registration
Prospero Registration Number CRD42021243185.
... Best-corrected visual acuity (BCVA) was recorded in Snellen and then converted to Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score with the "ETDRS= 85 + 50 × log10 (Snellen Fraction)" formula 16 for statistical calculations. ...
Purpose
Some patients with neovascular age-related macular degeneration (nAMD) do not respond to anti-VEGF treatment or develop tolerance or tachyphylaxis. If optimal treatment response is lacking with a given drug, switching to another is a common practice. The aim of this study was to report short-term outcomes of treatment switch to faricimab in real-world patients with nAMD resistant to both aflibercept and ranibizumab.
Design
Single-center, retrospective real-world cohort study.
Methods
Chart-review of 13 eyes of 13 multi-switch patients using electronic injection database, electronic medical records, and optical coherence tomography (OCT) data from May–September 2023.
Results
Faricimab treatment led to absence of fluid (subretinal, or both subretinal and intraretinal fluid) in 31% of the eyes and a reduction of fluid in 77% of the eyes at 4 weeks following the switch. The best-corrected visual acuity did not change significantly. No ocular or systemic safety events were observed.
Conclusions
Switching to faricimab seems a reasonable option in patients with nAMD who were previously resistant to both aflibercept and ranibizumab treatment. We noted a high rate of morphological response and improvement in anatomical parameters, with nearly one-third of the patients achieving dry macula after just one injection. No change in BCVA was seen. No safety issues were noted. The durability of these results warrants additional investigations.
... The conversion of BCVA from Snellen to logMAR could also result in inaccuracies as the relationships between the two measures are not directly proportional. [36,37] Furthermore, a relatively high percentage (25%) of postoperative rpVH may be partly due to the fact that intraoperative electrocoagulation on the tumor's feeder and draining blood vessels was not performed, unlike previous series. [25] Nevertheless, all cases with rpVH spontaneously resolved with no need of further surgery. ...
PURPOSE
The purpose of this study was to compare surgical indications, functional outcomes, and postoperative complications of stand-alone pars plana vitrectomy (PPV) versus PPV with retinopexy for retinal vasoproliferative tumors (RVPTs).
METHODS
Retrospective multicenter cohort study: 12 consecutive pars plana vitrectomies in 12 eyes with RVPTs performed either stand alone (Group S), or associated with intraoperative retinopexy on the RVPT (Group R) between April 2017 and December 2020 were included.
RESULTS
Surgical indications included epiretinal membranes (ERMs) (42%), vitreous opacities (25%), recurrent-persistent vitreous hemorrhage (VH) (17%), rhegmatogenous retinal detachment with proliferative vitreoretinopathy (8%), and biopsy of retinal lesion (8%). The mean preoperative best-corrected visual acuity (BCVA) was 0.97 ± 0.78 logarithm of the minimal angle of resolution (logMAR) in Group S and 1.09 ± 0.67 in Group R ( P = 0.344). The mean postoperative follow-up was 29.33 ± 8.73 in Group S and 27.66 ± 16.93 months in Group R ( P = 0.424). The mean postoperative BCVA was 1.29 ± 0.94 logMAR in Group S and 0.32 ± 0.19 in Group R ( P = 0.115). Compared to preoperatively, postoperative BCVAs significantly improved in Group R ( P = 0.012). The final BCVA ≥20/80 logMAR was achieved in 2 (33%) cases in Group S and in 6 (100%) cases in Group R. Complications included recurrent-persistent VH ( n = 3) and dragged fovea ( n = 1) in Group S (67%) and ERM ( n = 1), cystoid macular edema ( n = 1), and subretinal exudation ( n = 1) in Group R (50%).
CONCLUSION
Vitrectomy in RVPTs seemed efficacious and safe for certain indications. Functional outcomes and complications appeared to be superior in eyes which underwent retinopexy on RVPTs compared to the stand-alone vitrectomy group.
... The following outcomes were quantitatively assessed: (1) the mean changes in BCVA from the baseline, indicating functional improvement; (2) the mean changes in CMT from the baseline, indicating anatomical improvement. BCVA recorded as ETDRS letters and Snellen fraction were transformed to Logarithm of the Minimum Angle of Resolution, (LogMAR) [15]. ...
Intravitreal anti-vascular endothelial growth factor (anti-VEGF) injections have emerged as the most common therapeutic approach for the management of diabetic macular edema (DME). Despite their proven superiority over other interventions, there is a paucity of data regarding the relative effectiveness of anti-VEGF agents in treating DME diagnosed with different patterns of optical coherence tomography (OCT). In this regard, we conducted a systematic review and comparative analysis of the therapeutic efficacy of intravitreal bevacizumab, ranibizumab, aflibercept, and conbercept in the management of DME with diffuse retinal thickening (DRT), cystoid macular edema (CME), and serous retinal detachment (SRD) patterns identified using OCT. Our study encompassed a comprehensive search of PubMed, Embase, Web of Science, China National Knowledge Infrastructure (CNKI), and Wan Fang Data from their inception until January 25, 2023. The network meta-analysis involved the inclusion of 1606 patients from 20 retrospective studies with a moderate risk of bias but no evidence of publication bias. The DRT group had the highest increase in best-corrected visual acuity (BCVA) with anti-VEGF, while the SRD group had the greatest reduction in Central Macular Thickness (CMT). Furthermore, conbercept, ranibizumab, and bevacizumab, respectively, showed the best treatment outcomes for patients with DRT, CME, and SRD in terms of improvement in BCVA. And, conbercept exhibited the highest reduction in CMT in the DRT, CME, and SRD groups. In conclusion, our study highlights the efficacy of anti-VEGF agents in the management of DME and provides valuable insights into the selection of anti-VEGF agents tailored to the individual needs of patients.
... A p-value of less than 0.05 was considered statistically significant. Using the method proposed by Gregori et al., 35 we standardized the visual acuity scores to the minimum angle of resolution (logMAR) chart scores. ...
Purpose
To review all studies reporting the occurrence of white dot syndromes (WDSs) following SARS-COV-2 infection.
Methods
On May 12, 2023, we registered our protocol on PROSPERO [registration number: CRD42023426012]. Five different databases including PubMed, Scopus, Web of Science, Google Scholar, and Science Direct were searched up to May 2023. We included all studies that reported the symptoms of WDSs following SARS-COV-2 infection. The data was extracted using a uniform Excel extraction sheet. All statistical tests were conducted with a 95% confidence interval and a 5% error margin. A p-value of less than 0.05 was considered statistically significant. The publication bias of included studies was assessed using JBI Critical Appraisal Checklist for Case Reports and IHE Quality Appraisal Checklist for Case Series studies.
Results
This review included thirty-two studies involving forty-eight patients. Acute macular neuroretinopathy was the most common disease (70.8%) followed by multiple evanescent white dot syndrome (14.6%) with 58.3% of WDS after their first SARS-COV-2 infection, and paracentral acute middle maculopathy (4.1%). They were mostly unilateral (56.2%). The presenting symptoms were blurred vision (70.8%), visual field disturbance (68.7%), and photopsia (20.8%). About 35.4% of the patients improved by their treatment and future complications were persistent scotoma (4.2%) and macular edema (2.1%).
Conclusion
White dot syndromes are very rare entities. Our findings suggest a possible association between white dot syndrome onset and SARS-COV-2 infection. We recommend ophthalmologists should be aware of this suggested association to deliver better management and patients’ care.
... 34 Visual acuity (VA) was measured using the early treatment diabetic retinopathy study (ETDRS) chart. 35,36 Stereoacuity was measured using an random dot stereogram chart. 37 Contrast sensitivity function (CSF) was measured using the quick CSF procedure with a two-alternative forced-choice (2AFC) grating orientation identification task. ...
Purpose:
This study aimed to explore the underlying mechanisms of the observed visuomotor deficit in amblyopia.
Methods:
Twenty-four amblyopic (25.8 ± 3.8 years; 15 males) and 22 normal participants (25.8 ± 2.1 years; 8 males) took part in the study. The participants were instructed to continuously track a randomly moving Gaussian target on a computer screen using a mouse. In experiment 1, the participants performed the tracking task at six different target sizes. In experiments 2 and 3, they were asked to track a target with the contrast adjusted to individual's threshold. The tracking performance was represented by the kernel function calculated as the cross-correlation between the target and mouse displacements. The peak, latency, and width of the kernel were extracted and compared between the two groups.
Results:
In experiment 1, target size had a significant effect on the kernel peak (F(1.649, 46.170) = 200.958, P = 4.420 × 10-22). At the smallest target size, the peak in the amblyopic group was significantly lower than that in the normal group (0.089 ± 0.023 vs. 0.107 ± 0.020, t(28) = -2.390, P = 0.024) and correlated with the contrast sensitivity function (r = 0.739, P = 0.002) in the amblyopic eyes. In experiments 2 and 3, with equally visible stimuli, there were still differences in the kernel between the two groups (all Ps < 0.05).
Conclusions:
When stimulus visibility was compensated, amblyopic participants still showed significantly poorer tracking performance.
... The VA collected in the eCRF was recorded as measured per routine clinical practice (e.g., Snellen). VA was converted to approximate Early Treatment Diabetic Retinopathy Study (ap-proxETDRS) letters for analysis using the method from Gregori and colleagues [21]. ...
Introduction: Understanding patient perspectives of treatment may improve adherence and outcomes. This study explored real-world patient experiences with anti-vascular endothelial growth factor (anti-VEGF) treatment for diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD). Methods: This multinational, non-interventional, quantitative, cross-sectional, observational survey assessed treatment barriers/burden, patient-reported visual functioning, and treatment satisfaction in DME and nAMD patients in the USA, the UK, Canada, France, Italy, and Spain. Treatment patterns and visual outcomes were extracted from medical charts. Regression models evaluated relationships between adherence, total missed visits, number of anti-VEGF injections, and clinical and patient-reported outcomes for visual functioning. Association between treatment satisfaction and aspects of burden were assessed. Results: The survey was completed by 183 DME and 391 nAMD patients. Patients had moderately high vision-related functioning (25-item National Eye Institute Visual Functioning Questionnaire score: mean = 74.8) and were satisfied with their current treatment (mean total score: Macular Disease Treatment Satisfaction Questionnaire = 59.2; Retinopathy Treatment Satisfaction Questionnaire = 61.3). Treatment satisfaction scores were worse with higher time-related impacts of treatment (nAMD/DME), higher impacts on finances and daily life (nAMD), negative impacts on employment and lower expectations for treatment effectiveness (DME). Most patients reported ≥1 barrier (66.1% DME, 49.2% nAMD patients) related to treatment (35.0%), clinic (32.6%), and COVID-19 (21.1%). Moreover, 44.9% of patients reported some impairment in activities of daily living. Work absenteeism was observed among >60% of working patients. Nearly one-quarter (24.2%) of patients needed ≥1 day to recover from intravitreal injections; most reported ≥30 min of travel time (73.7%) and clinic wait time (54.2%). In unadjusted univariable analyses, treatment adherence (vs. nonadherence) was related to higher most recent visual acuity (β = 8.98 letters; CI, 1.34–16.62) and lower odds of visual acuity below driving vision (≤69 letters) (OR = 0.50; CI, 0.25–1.00). Conclusion: More durable treatments with reduced frequency of injections/visits may reduce treatment burden and improve patient satisfaction, which may enhance adherence and visual outcomes.
... 0.994 9 SS-OCT [26]. The Monoyer scale for distance visual acuity was used and then converted into logMAR and into Early Treatment Diabetic Retinopathy Study (ETDRS) letters [27]. ...
The aim of this work is to evaluate the real-world outcomes of the reinforced treat-and-extend (RTE) protocol for the treatment of exudative age-related macular degeneration with intravitreal injections of aflibercept or ranibizumab (anti-vascular endothelial growth factor therapies).
This was a retrospective review of patients from two tertiary ophthalmology centers in France initiating the RTE protocol between February 2018 and June 2021. The primary outcome was change in best-corrected visual acuity (BCVA) after 24 months. Secondary outcomes were change in central retinal thickness (CRT), recurrence, and management-related factors (injection interval, number of injections/consultations). Outcomes were additionally evaluated after protocol changes (strict versus modified RTE protocol groups).
Sixty-eight patients (72 eyes) were included (68% females; mean age 82.2 ± 7.8 years). After 24 months, mean BCVA significantly improved (65.22 ± 14 vs. 71.96 ± 13 Early Treatment Diabetic Retinopathy Study letters; p < 0.001) and CRT significantly decreased (388.6 ± 104 vs. 278.8 ± 51 μM; p < 0.001) with 21% of eyes showing signs of exudation. Over the 24 months, a mean total of 14.9 ± 4.0 injections and 8.6 ± 1.4 consultations were performed. Mean 24-month injection interval was 7.9 ± 2.3 weeks. Initial and 24-month ophthalmic outcomes for eyes in the strict (47%) versus modified (53%) groups were not significantly different, but mean time interval to first recurrence of disease activity was significantly shorter for the modified group (7.3 ± 2.4 vs. 9.9 ± 2.5 weeks; p < 0.001). Patients in the strict RTE group received significantly less injections (13.9 ± 3.6 vs. 16.5 ± 3.9; p = 0.006) and mean 24-month injection interval was significantly longer (9.5 ± 2.7 vs. 6.5 ± 2.1 weeks; p < 0.001). Consultation number was similar (8.5 ± 1.9 vs. 8.8 ± 1.6; p = 0.93). Treatment with aflibercept versus ranibizumab did not influence ophthalmic or management outcomes.
The RTE protocol, even when modified, reduced consultations but improved ophthalmic outcomes. The RTE protocol could reduce hospital visits and overall burden while also encouraging better patient compliance.
Video Abstract available for this article.
VIDEO ABSTRACT: Vincent Soler and François-Philippe Roubelat summarize the Reinforced Treat-and-Extend Protocol and main results (MP4 225022 KB)
... The guiding principle of resolution is consistency across all viewing distances, ensuring a uniform visual angle regardless of the viewing distance. Regarding an individual with normal vision (20/20 visual acuity) positioned 6 m from the computer screen, the letters occupy a visual angle of 5 min of arc 64,65 , corresponding to 0.873 cm. However, when the distance is reduced to 3 m, if the letter size is maintained, it results in a larger visual angle that is not equivalent to the 5 arcminutes visual angle. ...
Crowding is a phenomenon in which the ability to recognize an object in a clutter deteriorates. It is, therefore, a fundamental aspect of object recognition and crucial in deciphering resolution. For visually impaired individuals, deficiency in crowding has a tremendous effect on vision and may reflect and predict the amount of deterioration in vision. It is well established that albinos suffer much more from crowding than normally sighted individuals under daylight luminance conditions. However, to our knowledge, this study is the first to investigate crowding in albino participants under low light conditions. In this study, we explored the crowding effect in a group of albino participants (n = 9) and a control group of normally sighted participants (n = 9). Crowding was conducted under daylight (photopic vision) and low light (scotopic vision). We measured the visual acuity threshold under crowding in three-letter spacing (0.5, 1, and 1.5) and compared it to a single target. Results indicate that albino participants experienced stronger crowding than the control under the photopic condition, while crowding under the scotopic condition was apparent in the albino but abolished for the control group. These findings highlight the importance of considering luminance when discussing the visually impaired population in general. In particular, it suggests that crowding in albinism is based on a peripheral-like mechanism and may indicate a cessation in visual development.
... Te nonresponder group was considered to be patients with moderate or no resolution of the subretinal fuid. Snellen BCVA was converted into the logarithm of the minimal angle of resolution (logMAR) score for statistical analysis [15]. Continuous data are presented as mean-± standard deviation (SD) and categorical variables as counts and percentages. ...
Purpose. To evaluate the efficacy of spironolactone in the treatment of chronic central serous chorioretinopathy (CSC) and identify imaging characteristics that can predict the benefit of spironolactone treatment. Methods. Patients with chronic CSC were treated with spironolactone (20 mg/tid) and followed for 6 months. The primary outcome measure was complete resolution of the subretinal fluid (SRF), and the best-corrected visual acuity (BCVA), the SRF area, the central macular thickness (CMT), the subfoveal choroidal thickness (SFCT), and the density of the choriocapillaris vessel and adverse events were secondary outcome measures. Patients who presented complete resolution of SRF were included in the responder group and the other patients who had moderate or no resolution were included in the nonresponder group. Imaging characteristic comparisons between the responder and nonresponder groups were performed with regression analyses to identify factors that are predictive of a good response to treatment. Results. Forty-two eyes of 42 patients with a mean age of 46.06 ± 6.66 years were included. A total of 57.1% of the patients achieved a complete resolution of SRF. The mean SRF area, CMT, and SFCT decreased significantly (all P<0.05) throughout the follow-up period and BCVA improved slightly (P>0.05). The vascular density of the choriocapillaris of the fellow eyes did not vary significantly during treatment. Logistic regression analysis revealed that SFCT (P=0.002) and the intact ellipsoid zone (P=0.001) were correlated with disease resolution. A relatively higher baseline SFCT was a predictive factor associated with a good response to treatment according to multivariate analysis. Conclusions. This study suggested that oral spironolactone could be an effective and safe therapy for chronic CSC patients. Eyes with a higher baseline SFCT and intact ellipsoid zone could have a good response. These parameters are an important prognostic marker.
... All patients in the database of Vista Augenklinik Binningen, Switzerland, diagnosed with RPE tears confirmed by SD-OCT (Spectralis, Heidelberg Engineering, Heidelberg, Germany) with a minimum follow-up period of 12 months and best-corrected visual acuity (BVCA) of 0.1 standard Snellen (35 ETDRS letters) were included (21 eyes of 21 patients). Standard Snellen BVCA measurements were performed during each consultation and converted to ETDRS letter scores for the purpose of the study [19]. ...
Background The goals of this study are to evaluate potential long-term visual deterioration associated with retinal pigment epithelial (RPE) tears in patients with neovascular age-related macular degeneration (nAMD) and to find treatment-related and morphological factors that might influence the outcomes.
Patients and Methods This retrospective study enrolled 21 eyes of 21 patients from the database of Vista Eye Clinic Binningen, Switzerland, diagnosed with RPE tears, as confirmed by spectral domain optical coherence tomography (SD-OCT), with a minimum follow-up period of 12 months. Treatment history before and after RPE rupture with anti-VEGF therapy, visual acuity, and imaging (SD-OCT) were analyzed and statistically evaluated for possible correlations.
Results Mean patient age was 80.5 ± 6.2 years. The mean length of total follow-up was 39.7 ± 13.9 months. The mean pigment epithelial detachment (PED) height increased by 363.8 ± 355.5 µm from the first consultation to 562.8 ± 251.5 µm at the last consultation prior to rupture. Therefore, a higher risk of RPE rupture is implied as a result of an increase in PED height (p = 0.004, n = 14). The mean visual acuity before rupture was 66.2 ± 16.0 letters. Mean visual acuity deteriorated to 60.8 ± 18.6 letters at the first consultation after rupture (p = 0.052, n = 21). A statistically nonsignificant decrease in vision was noted in the follow-up period. After 2 years, the mean BCVA decreased by 10.5 ± 23.7 ETDRS letters (p = 0.23, n = 19). PED characteristics before rupture and amount of anti-VEGF injections after rupture did not affect the visual outcome. None of the 21 patients included in our study showed a visual improvement in the long-term follow-up. RPE atrophy increased significantly from 3.35 ± 2.94 mm² (baseline) to 6.81 ± 6.25 mm² over the course of 2 years (p = 0.000 013, n = 20).
Conclusions The overall mean vision decrease after rupture was without statistical significance. There was no significant change in BCVA at the 2-year follow-up, independent of the amount of anti-VEGF injections provided. In this study, there was a significant increase in RPE defect over a follow-up of 2 years, implying progression of contraction of RPE and/or macular atrophy.
... Collected data included demographics (age, sex), treatment history (number and type of previous treatments), best corrected visual acuity (BCVA), central retinal subfield thickness (CRT), presence of pigment epithelial detachment (PED) and PED height if applicable, type of retinal fluid (intra-or subretinal or both) before the treatment switch, presence or absence of residual fluid in case of favorable therapeutic response, time of reappearance of the fluid in case of dry macula after the first faricimab injection, and adverse events after the treatment switch. Visual acuity was measured in Snellen and was subsequently converted to Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA score with the "ETDRS = 85 + 50 × log 10 (Snellen Fraction)" formula [13] for statistical calculations. CRT and PED measurements and retinal fluid type classifications were done using IMAGEnet 6 (software version 1.31.18920, ...
Purpose
To report short-term outcomes of treatment switch to faricimab in real-world patients with aflibercept-resistant neovascular age-related macular degeneration (AMD).
Methods
Single-center, retrospective cohort study with chart-review using electronic injection database, electronic medical records, and optical coherence tomography (OCT) data from May to September 2023.
Results
A total of 50 eyes of 46 patients were analyzed. Faricimab treatment led to absence of fluid in 32% of the eyes and a reduction of fluid in 84% of the eyes. There was a statistically significant decrease in central retinal thickness (CRT) and pigment epithelial detachment (PED) height in those that responded to the switch (median difference: − 31 μm, IQR: 55, p < 0.0001 and median difference: − 21 μm, IQR: 36, p < 0.0001, respectively) and a statistically significant increase in CRT (median difference: + 19 μm, IQR: 20, p = 0.0143) and no change in PED height (median difference: + 22 μm, IQR: 64, p = 0.1508) in those that did not.
Best-corrected visual acuity (BCVA) showed marginal decrease with low statistical significance. No ocular or systemic safety events were observed.
Conclusions
Our findings suggest that switching to faricimab is generally safe and effective in patients with neovascular AMD who are otherwise difficult to treat and have residual fluid despite frequent injections with aflibercept. We observed a high rate of morphological response to the treatment switch, improvement of anatomical parameters with about one-third of patients having dry macula following a single injection, and a marginal change in BCVA. Sustainability of these results requires further investigation.
Study registration
ClinicalTrials.gov registration number: NCT06124677. Date of registration: 09/11/2023, retrospectively registered.
... VA was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) letters. In cases where such values were not available, Snellen values were converted to ETDRS letters as per Gregori et al. 2010 [17]. Types of treatment regimen included: fixed regimen, meaning a fixed treatment interval is chosen and maintained; Treat & Extend (T&E), a proactive regimen whereby the patient receives an injection at every visit, and the injection interval is either shortened or extended depending on the status of the macula; pro re nata (PRN), a conservative approach where treatment is only given in case of active disease. ...
Background
The purpose of the study was to compare the real-world aflibercept treatment and visual outcomes, and to examine the adherence to pandemic guidelines in two groups of patients with treatment-naïve neovascular age-related macular degeneration (nAMD) before and during the first year of the COVID-19 pandemic in Sweden up to the 1-year follow-up.
Methods
This is a retrospective observational study including 2915 treatment naïve eyes with nAMD. Using data from the Swedish Macula Register (SMR), 1597 eyes initiating treatment between 1 July 2018 and 31 January 2019 (pre-pandemic group) were compared with 1318 eyes starting treatment between 1 February and 31 August 2020 (pandemic group). The eyes were then followed for 1 year ± 2 months, hence the first group was unaffected by the pandemic while the second group was affected. The focus was on baseline characteristics, visual acuity (VA) change from baseline, number of injections, treatment regimen, number of appointments and the frequency and length of appointment delays. The Wilcoxon Signed-Rank Test was used to compare baseline VA to follow-up VA within the respective groups. The Mann-Whitney U-test and Fisher’s exact test were used to compare outcomes between the groups.
Results
Baseline characteristics were similar between the two groups. The percentage of eyes with an available follow-up VA after 1 year was 58% in the pre-pandemic group vs. 44% in the pandemic group. VA in the pre-pandemic group had increased significantly after 1 year, from 62.2 ± 14.1 letters to 64.8 ± 16.1 letters (n = 921); p < 0.0001. In the pandemic group, VA increased from 61.1 ± 15.8 to 64.9 ± 16.9 (n = 575); p < 0.0001. There was no significant difference in mean VA change between the groups; p = 0.1734. The pre-pandemic group had significantly more delays than the pandemic group, 45% vs. 36%; p < 0.0001.
Conclusions
The pre-pandemic and pandemic groups had similar VA gains at 1-year follow-up, but with a reduced number of available VA in the pandemic group. Clinics were able to implement and prioritize injection visits excluding VA measurements, helping to reduce delays and maintain VA gains during the COVID-19 pandemic.
... Uncorrected visual acuity (UCVA) and best-spectaclecorrected visual acuity were measured using a Snellen eye chart at 5 m. The Snellen fraction was converted to approximate ETDRS (approxETDRS) letter scores, for statistical manipulations using the strategy proposed by Ninel Z [16]. ...
Background
To investigate the effect of different sizes of pterygium on the front and back corneal topography, refractive changes and aberrations in natural-light and low-light conditions.
Methods
Sixty subjects with unilateral primary nasal pterygium were enrolled in this study. All the patients’ uncorrected, best spectacle-corrected visual acuity, corneal topographic aberration data in 3 mm and 7 mm areas were collected. The pterygium size was evaluated by the slit-lamp photography and Sirius Scheimpflug Analyzer.
Results
The front topographic astigmatism values, corneal total aberrations, and higher-order aberrations in 3 mm and 7 mm areas were higher in the pterygium group than those in the control group. The pterygium horizontal length and thickness were moderately to strongly correlated with astigmatism and RMS of aberrations, while pterygium vertical length showed no or just mild correlation with the corneal astigmatism and aberrations. Compared to the readings in 3 mm area, the front and back corneal astigmatism and aberrations were larger in 7 mm area.
Conclusions
Pterygium led to visual impairment by inducing astigmatism and aberrations. In low-light condition, the visual function worsened due to increased corneal astigmatism values and aberrations.
... Visual acuity will be collected as per usual practice and automatically converted to approximate ETDRS letters in the eCRF. 30 Data on both eyes will be collected, irrespective of disease status and administered treatments. ...
Purpose
To describe the rationale and design of the VOYAGER (NCT05476926) study, which aims to investigate the safety and effectiveness of faricimab and the Port Delivery System with ranibizumab (PDS) for neovascular age-related macular degeneration (nAMD) or diabetic macular edema (DME) in clinical practice. VOYAGER also aims to understand drivers of clinical practice treatment outcomes by gaining novel insight into the intersection of treatment regimens, decisions, anatomic outcomes, and vision.
Design
Primary data collection, noninterventional, prospective, multinational, multicenter clinical practice study.
Participants
At least 5000 patients initiating/continuing faricimab or PDS for nAMD/DME (500 sites, 31 countries).
Methods
Management will be per usual care, with no mandated scheduled visits/imaging protocol requirements. Using robust methodologies, relevant clinical and ophthalmic data, including visual acuity (VA), and data on treatment clinical setting/regimens/philosophies, presence of anatomic features, and safety events will be collected. Routinely collected fundus images will be uploaded to the proprietary Imaging Platform for analysis. An innovative investigator interface will graphically display the patient treatment journey with the aim of optimizing treatment decisions.
Main Outcome Measures
Primary end point: VA change from baseline at 12 months per study cohort (faricimab in nAMD and in DME, PDS in nAMD). Secondary end points: VA change over time and per treatment regimens (fixed, treat-and-extend, pro re nata, and other) and number. Exploratory end points: VA change in relation to presence/location of anatomic features that impact vision (fluid, central subfield thickness, fibrosis, atrophy, subretinal hyperreflective material, diabetic retinopathy severity, and disorganization of retinal inner layers) and per treatment regimen/philosophies. The impact of regional and practice differences on outcomes will be assessed as will safety.
Results
Recruitment commenced in November 2022 and will continue until late 2027, allowing for up to 5 years follow-up. Exploratory interim analyses are planned annually.
Conclusions
VOYAGER is an innovative study of retinal diseases that will assess the effectiveness and safety of faricimab and PDS in nAMD and DME and identify clinician- and disease-related factors driving treatment outcomes in clinical practices globally to help optimize vision outcomes.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
... Statistical significance was evaluated by paired t-test analysis, and P-values below 0.05 were considered statistically significant. P-values and 95% CIs of the mean differences between respective baseline and Month 12 or Month 18 measurements were reported and displayed in figures using the statistical software R. VA was converted from Snellen numerators, denominators and logMAR values to Early Treatment Diabetic Retinopathy Study (ETDRS) letters as described by Gregori et al. 30 Missing value analyses were performed by calculating the percentage of missing values at baseline and at Month 12 and Month 18, respectively. ...
Objective
Retrospective, real-world study to evaluate visual acuity (VA), anti-vascular endothelial growth factor (anti-VEGF) injection intervals, and central macular thickness (CMT) in neovascular age-related macular degeneration (nAMD) eyes switched to brolucizumab only or to brolucizumab alternating with another anti-VEGF.
Methods
The overall study population comprised eyes that were given ≥1 brolucizumab injection between 1 October 2019 and 30 November 2021. The brolucizumab-only (BRO) cohort consisted of prior anti-VEGF-treated eyes treated exclusively with ≥3 brolucizumab injections over ≥12 or ≥18 months; the alternating brolucizumab (ALT) cohort comprised prior anti-VEGF-treated eyes treated with ≥2 brolucizumab injections and ≥1 other anti-VEGF over ≥12 or ≥18 months.
Results
A total of 482 eyes received ≥1 brolucizumab injection during the study period. Mean VA changes from baseline were −1.1±15.1 letters (BRO cohort; n = 174) and 1.3±13.0 letters (ALT cohort; n = 47) at Month 12, and 0.0±13.5 letters (BRO cohort; n = 95) and −7.3±17.2 letters (ALT cohort; n = 29) at Month 18. Mean changes in injection intervals were +26.9±48.1 days (BRO cohort) and +11.1±17.3 days (ALT cohort) at Month 12 and +36.3±52.3 days (BRO cohort) and +14.0±19.9 days (ALT cohort) at Month 18. Mean changes in CMT were −35.2±108.1 μm (BRO cohort) and −31.5±91.2 μm (ALT cohort) at Month 12 and −38.9±75.0 μm (BRO cohort) and −9.0±59.9 μm (ALT cohort) at Month 18. Intraocular inflammation-related adverse events were recorded in 22/482 (4.6%) eyes.
Conclusion
Treatment with either brolucizumab alone or brolucizumab alternating with another anti-VEGF can preserve vision, reduce CMT, and extend anti-VEGF injection intervals in patients with nAMD.
... Visual acuity change from baseline was calculated as best-documented visual acuity in approximate ETDRS letters from reported measures and were converted from either Snellen (ETDRS ¼ 85 þ 50 Â log [Snellen fraction]) or logarithm of the maximum angle of resolution values. 26 The frequency of intravitreal anti-VEGF injections by followup year and the duration of gaps between injections were determined for the overall cohort. At the time of the study, all anti-VEGF agents were indicated for treatment intervals 16 weeks; therefore, a period of > 18 weeks (up to 52 weeks) without an anti-VEGF injection was defined as a treatment gap. ...
Purpose
To evaluate anti-VEGF treatment patterns and the influence of patient demographic and clinical characteristics on up to 6-year vision outcomes in neovascular age-related macular degeneration.
Design
Retrospective, multicenter, noninterventional registry study with up to 6 years of follow-up.
Participants
A cohort of 254 655 eyes (226 767 patients) with first anti-VEGF injection and at least 2 years of follow-up; 160 423 eyes had visual acuity (VA) data.
Methods
Anonymized patient data were collected in the United States through the IRIS® Registry (Intelligent Research in Sight).
Main Outcome Measures
Changes in VA from baseline; frequency of and gaps between intravitreal anti-VEGF injections; treatment discontinuations; switching anti-VEGF agents; and influence of baseline clinical and demographic characteristics on VA.
Results
After a mean VA increase of 3.0 ETDRS letters at year 1, annual decreases led to a net loss from baseline of 4.6 letters after 6 years. Patients with longer follow-ups had better baseline and follow-up VA. From a mean of 7.2 in year 1 and 5.6 in year 2, mean injections plateaued between 4.2 to 4.6 in years 3 through 6. Treatment was discontinued in 38.8% of eyes and switched in 32.3%. When adjusting for differences at baseline, every additional injection resulted in a 0.68 letter improvement from baseline to year 1; thus, multiple injections in a year have the potential to be clinically meaningful. Older age, male gender, Medicaid insurance, and not being treated by a retina specialist were associated with a higher likelihood of vision loss at year 1. Of the patients, 58.5% lost ≥ 10 letters VA at least once during follow-up, with 14.5% of patients experiencing sustained poor vision after a median of 3.4 years.
Conclusions
After modest mean VA improvement with intravitreal anti-VEGF injections at year 1, patients netted a loss of VA by year 6. Injection frequency decreased over time, and this was paired with a relatively high rate of discontinuation. Modeling suggested that more frequent injections were associated with better VA. Difficulty with continuous adherence to frequent intravitreal injections may have contributed to undertreatment resulting in less-than-optimal vision outcomes.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
... To show the magnitude of the intervention effect, the baseline BCVA and its mean change were converted to approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. 14 The methodological quality of each included study was discussed among the three authors (AAV, THG, HS) using the Risk of Bias in Non-randomized Studies of Interventions (ROBINS-I) tool. 15 The assessment covered seven domains: bias due to confounding, bias in selection of participants into the study, bias in classification of interventions, bias due to deviations from intended interventions, bias due to missing data, bias in measurement of outcomes, and bias in selection of reported results. ...
Background
In patients predisposed to radiation retinopathy (RR), administration of therapy after apparent clinical signs and symptoms are considered too late, resulting in substantial vision loss and blindness. Early initiation of anti-vascular endothelial growth factor (anti-VEGF) might serve as a strategy to slow disease progression and prolong good eyesight.
Objective
To evaluate the efficacy of prophylactic anti-VEGF in preventing RR and preserving vision in patients at high risk of radiation-induced vision loss.
Methods
A systematic literature search was performed from inception to 4 June 2023 using Cochrane Library, EMBASE, PubMed (MEDLINE), and Scopus. Eligible studies were clinical trials and observational studies investigating the incidence of radiation maculopathy (RM), radiation optic neuropathy (RON), moderate vision loss (loss of more than or equal to 3 lines of baseline visual acuity [VA]) and final VA, whether good (20/40 or better) or poor (20/200 or worse), following prophylactic anti-VEGF. Three reviewers independently conducted article screening, data extraction and risk of bias assessment. Random effects models were used to determine the cumulative effects of each outcome.
Results
Four studies (one clinical trial and three observational studies), involving 2109 patients, were included in our analysis. Across all studies, there were significant reductions in the events of RM (pooled odds ratio [OR] 0.50; 95% CI, 0.34–0.74; p = 0.001), RON (pooled OR 0.62; 95% CI, 0.42–0.90; p = 0.012) and poor final VA (pooled OR 0.50; 95% CI, 0.37–0.68; p = 0.003). The association of moderate vision loss and good final VA with the use of prophylactic anti-VEGF between the groups was unclear owing to the high level of heterogeneity.
Conclusion
Prophylactic anti-VEGF therapy might delay RM and RON, preventing high-risk patients from developing poor VA by approximately 50%. However, this evidence should be interpreted with caution because of its low level of certainty. Future robust studies are warranted to confirm this finding.
... Visual outcomes were preferably assessed using best-corrected visual acuity (BCVA) as evaluated with Early Treatment Diabetic Retinopathy Study (ETDRS) charts; where ETDRS charts were unavailable, BCVA was evaluated using other methods (e.g., Snellen charts). In regions where BCVA was not part of the standard of care, conventional VA measurements were conducted and the data were later converted into ETDRS letter scores for statistical analysis [24]. Central retinal thickness (CRT) was measured by time-domain or spectral-domain optical coherence tomography (SD-OCT) using the instrument available at each site, and data generated by time-domain optical coherence tomography were converted to SD- OCT measurements for later analysis [25]. ...
AURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) treatment of diabetic macular edema or macular edema secondary to retinal vein occlusion (RVO) in routine clinical practice. Here, we report the 24-month outcomes in the RVO cohort from France, Germany, Italy, and Taiwan.
AURIGA (NCT03161912) was a prospective observational study. Eligible patients with RVO were enrolled for whom the decision to treat with IVT-AFL had already been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month (M) 12. All statistical analyses were descriptive.
In 554 treatment-naïve and 65 previously treated patients with RVO, the respective mean (95% confidence interval) change in VA from baseline was + 12.5 (10.8, 14.3) and + 7.9 (3.3, 12.6) letters by M12 and + 11.4 (9.4, 13.3) and + 4.4 (− 0.6, 9.5) letters by M24 (baseline mean ± standard deviation: 51.0 ± 21.9 and 51.9 ± 20.4 letters); 44.0% of treatment-naïve and 27.9% of previously treated patients reported ≥ 15-letter gains by M24. By M24, the mean change in central retinal thickness from baseline was − 247 (− 267, − 227) µm in treatment-naïve patients and − 147 (− 192, − 102) µm in previously treated patients. From baseline to M6, M12, and M24, treatment-naïve patients received a total of 4.0 ± 1.3, 5.5 ± 2.5, and 6.9 ± 4.2 injections, respectively, and previously treated patients received 3.8 ± 1.5, 5.0 ± 2.2, and 6.3 ± 3.7 injections, respectively. The safety profile of IVT-AFL was consistent with that of previous studies.
In AURIGA, patients with RVO experienced clinically relevant functional and anatomic improvements following IVT-AFL treatment in routine clinical practice. These improvements were largely maintained in treatment-naïve patients over the 24-month study despite the decreasing treatment frequency, suggesting long-term durability of IVT-AFL treatment outcomes. Infographic available for this article.
ClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017).
... Where ETDRS charts were unavailable, BCVA was assessed using other methods, including Snellen charts. In regions where BCVA was not part of the standard of care, conventional VA measurements were conducted and the data were later converted into ETDRS letter scores for statistical analysis [17]. Central retinal thickness (CRT) was measured by time-domain or spectral-domain optical coherence tomography (time-domain OCT/SD-OCT) using the instrument available at each site, and data generated by time-domain OCT were converted to SD-OCT measurements for later analysis [18]. ...
AURIGA is the largest real-world study to date to evaluate intravitreal aflibercept (IVT-AFL) in the treatment of diabetic macular edema (DME) or macular edema secondary to retinal vein occlusion in routine clinical practice. The 24-month outcomes in the DME cohort from across 11 participating countries are reported here.
AURIGA (NCT03161912) was a prospective observational study. The study enrolled eligible patients with DME for whom the decision to treat with IVT-AFL had previously been made by the attending physician. Patients were treated with IVT-AFL for up to 24 months at physician discretion according to local practice. The primary endpoint was mean change in visual acuity (VA; Early Treatment Diabetic Retinopathy Study [ETDRS] letters) from baseline to month 12 (M12). All statistical analyses were descriptive.
In 1478 treatment-naïve and 384 previously treated patients with DME, the mean (95% confidence interval) change in VA from baseline was +6.7 (5.7, 7.6) and +7.4 (5.5, 9.4) letters by M12 and +5.9 (4.9, 6.9) and +8.1 (6.1, 10.1) letters by M24 (baseline [mean ± standard deviation]: 56.0 ± 19.8 and 50.8 ± 19.5 letters), respectively; 25.9% of treatment-naïve and 32.8% of previously treated patients achieved ≥ 15-letter gains by M24. The mean change in central retinal thickness from baseline to M24 was −110 (−119, −102) µm in treatment-naïve patients and −169 (−188, −151) µm in previously treated patients. By M6, M12, and M24, treatment-naïve patients had received 3.8 ± 1.7, 4.9 ± 2.8, and 5.7 ± 3.9 injections, respectively, and previously treated patients had received 3.9 ± 1.5, 4.9 ± 2.4, and 6.2 ± 3.6 injections, respectively. The safety profile of IVT-AFL was consistent with previous studies.
In AURIGA, treatment-naïve and previously treated patients with DME achieved clinically relevant functional and anatomic improvements following IVT-AFL treatment for up to 24 months in routine clinical practice. Even with the decreasing injection frequency observed, these gains were largely maintained throughout the study, suggesting long-term durability of the positive effects of IVT-AFL treatment. Infographic available for this article.
ClinicalTrials.gov Identifier: NCT03161912 (May 19, 2017).
... Snellen VA was converted to approximate Early Treatment for Diabetic Retinopathy Study (ETDRS) letters for statistical analysis. 10,11 Patients with VA of count fingers (CF) or worse were assigned an ETDRS letter score of 0. ...
Importance
Brolucizumab (Beovu®) is an anti-vascular endothelial growth factor (anti-VEGF) agent approved for the treatment of neovascular age-related macular degeneration (nvAMD). Brolucizumab was marketed for its noninferiority to aflibercept and its potential for greater durability. However, post-marketing utilization has been tempered by safety concerns.
Objective
We evaluate the visual and anatomic efficacy of brolucizumab, examine changes in treatment intervals after switching to brolucizumab, and estimate the incidence of drug-related adverse events in the real world.
Design, Setting, and Participants
This was a retrospective consecutive case series of 626 eyes (543 patients) with nvAMD treated with 1438 brolucizumab injections at a single retina practice between 10/1/2019 and 5/15/2020.
Main Outcomes and Measures
Changes in visual acuity (VA); anatomic outcomes assessed by optical coherence tomography (OCT) including central subfield thickness (CST), macular volume (MV), presence of intraretinal fluid (IRF), subretinal fluid (SRF), and serous pigment epithelial detachment (sPED) on foveal line scans; treatment intervals before and after receiving brolucizumab; and the incidence of brolucizumab-related adverse events.
Results
The majority of eyes (N = 531, 89.7%) had received prior anti-VEGF therapy with aflibercept, ranibizumab, and/or bevacizumab. VA improved in treatment-naïve eyes (+3.7 letters, p = 0.04), and was maintained in previously treated eyes. There were significant improvements in all anatomic outcomes in both groups (p < 0.001). We observed a 4.8% incidence of intraocular inflammation (IOI) and a 0.6% incidence of retinal vasculitis. The average treatment interval increased from 6.3 to 6.8 weeks (p = 0.001).
Conclusions and Relevance
Brolucizumab treatment was associated with VA improvement in naïve eyes and maintenance of VA in previously treated eyes. Switching to brolucizumab was associated with improved anatomic outcomes and extended treatment intervals in most eyes. We observed a similar incidence of IOI and a lower incidence of retinal vasculitis compared to the Safety Review Committee’s analysis of HAWK and HARRIER.
... Conversion from Snellen to approximate ETDRS letters was performed using previously established formulas. 20,21 Repeated measures analysis of variance with Bonferroni correction was used to assess differences in VA, intraocular ...
Purpose:
A subset of patients with neovascular age related macular degeneration (nAMD) experience treatment burden and suboptimal response with anti-vascular endothelial growth factor (anti-VEGF) therapy. The aim of this study was to investigate the effect of switching to a novel bi-specific agent, faricimab, in patients with nAMD currently treated with anti-VEGF.
Design:
Retrospective, non-comparative cohort study.
Subjects, participants, and/or controls:
Patients with nAMD previously treated with anti-VEGF and switched to intravitreal faricimab injection (IFI) at the Cleveland Clinic's Cole Eye Institute.
Methods, intervention, or testing:
Switching and administration schedule of IFI was at the discretion of the clinician. Visual acuity (VA) and macular optical coherence tomography (OCT) parameters, including central subfield thickness (CST), maximum pigment epithelial detachment (PED) height and presence of subretinal (SRF) or intraretinal fluid (IRF), were assessed at baseline (day of first IFI) and after each IFI.
Main outcome measures:
CST and presence of IRF or SRF after at least 3 IFI.
Results:
126 eyes of 106 patients were included in the analysis with a mean follow-up time of 24.3±5.2 weeks. Prior to switching to IFI, patients received a mean of either aflibercept (20.0±18.4, mean±SD), bevacizumab (7±8.9), ranibizumab (1.9±8.5), or brolucizumab (0.3±1.6) injections. The most common agent used prior to switching to IFI was aflibercept (n=110, 87%), and the mean treatment interval with any anti-VEGF of 5.6±1.6 weeks prior to switching. CST was reduced from baseline after the first IFI (266.8±64.7 vs 249.8±58.6um, p=0.02) and persisted over the 3 IFIs (p=0.01). PED height was reduced after the 3rd IFI (249.6±179.0 vs 206.9±130.0um, p=0.01). Mean VA (62.9 vs 62.7 approximate EDTRS letters, p=0.42) and interval between injections was similar after the 3rd IFI compared to baseline (6.3 vs 5.7 weeks, p=0.16). Eleven (8.7%) eyes were switched back to their previous anti-VEGF, including 2 (1.6%) eyes from 1 patient with intraocular inflammation requiring cessation of IFI. There were no other adverse events from switching.
Conclusions:
Switching to faricimab resulted in a reduction in mean CST (-11.6um, p=0.01) and PED height (-44.2um, p=0.01) after 3 injections with stable VA and at a similar treatment interval to prior anti-VEGF therapy.
... The conversion of best corrected visual acuity from Snellen to logarithm of the minimal angle of resolution could cause inaccuracies as the relationships between the two measures are not directly proportional. 39,40 When diagnosed, exudative maculopathy was treated with different combinations of intensive topical steroids and non-steroidal anti-inflammatory drugs according to the preferences of the surgeons, and intravitreal/periocular injections were not performed in this series, unlike previous literature. 41 ...
Clinical relevance:
Primary retinectomy in eyes not previously vitrectomized has been previously rarely performed in a minority of cases, unlike non-primary retinectomies in vitrectomized eyes.
Background:
This paper aims to determine anatomical and functional outcomes of primary retinectomy, and to assess structural macular changes among successful cases.
Methods:
In this retrospective multicentre cohort-study, 35 primary retinectomies in eyes undergoing initial vitrectomy for rhegmatogenous retinal detachment complicated by proliferative vitreoretinopathy C or D between 2014 and 2021 were included. The mean follow-up duration was 48 ± 59.24 months among successes and 46.54 ± 20.99 months among unsuccesses (p = 0.483).
Results:
The anatomical success rate was 48.5% after one retinectomy and 60% after two retinectomies. Mean postoperative best corrected visual acuity (BCVA) was 1.85 ± 0.62 logMAR (6/425 Snellen equivalent). The difference from mean preoperative BCVA was not significant (p = 0.312). Final BCVA ≥ 6/60 was achieved in 17% of cases, and no cases gained ≥6/24. Final mean postoperative BCVA of successes was 1.69 ± 0.60 logMAR (6/294 Snellen equivalent) compared with 2.10 ± 0.57 logMAR (6/756 Snellen equivalent) of unsuccessful cases (p = 0.101). Post-operative macular optical coherence tomography was obtained from 95% of successes. Normal macular profile was found in 10% of cases, and the other cases demonstrated exudative maculopathy (60%), tractional maculopathy (20%) and macular atrophy (10%). Final BCVA was significantly higher in eyes with normal macular status compared to eyes with exudative maculopathy (p = 0.045) and macular atrophy (p = 0.025).
Conclusion:
Primary retinectomy may be used for rhegmatogenous retinal detachment complicated with advanced proliferative vitreoretinopathy. Anatomical and functional outcome were inferior than non-primary retinectomies for grade C proliferative vitreoretinopathy. Functional outcome was influenced by macular status. Positive prognostic factors include final anatomical success and normal final macular anatomy.
Introduction:
Half-dose photodynamic therapy (HD-PDT) with verteporfin is the mainstay treatment in central serous chorioretinopathy (CSC). Since 2021, there is a worldwide shortage of verteporfin. This called for adjustments of daily practice. Here, we provide a comprehensive evaluation of the adapted treatment methods and outcomes in patients with non-resolving and chronic CSC.
Methods:
In this retrospective cohort study, we compared patients referred in the year before the verteporfin shortage (group 1), with patients referred in the first year of verteporfin shortage (group 2). Treatment strategies, subretinal fluid (SRF) resolution, and visual acuity (VA) were evaluated during a follow-up period of at least 4 months.
Results:
Eighty-five eyes of 79 patients were analyzed, 36 eyes in group 1 and 49 in group 2. The treatment strategy at the first visit shifted from HD-PDT as the most performed treatment in group 1 to a more patient-tailored approach in group 2, with a wait-and-see policy in most cases. During follow-up, HD-PDT was performed significantly less in group 2 (89% vs. 45%; p < 0.001). At a mean follow-up time of 6.2 months, SRF resolved in 61% of the eyes in group 1 and in 55% in group 2 (p = 0.821). No difference in VA was observed between the groups at follow-up (p = 0.637).
Conclusion:
During the shortage of verteporfin, a different treatment strategy was applied, with HD-PDT being performed less frequently. By implementing a more patient-tailored approach, the VA and the resolution rate of SRF remained similar to the year before the shortage.
Purpose
To identify risk factors and effect modifiers associated with intraocular inflammation (IOI) following brolucizumab injection.
Methods
Our protocol was registered on PROSPERO (CRD42022382645). We searched six electronic databases (PubMed, Scopus, Web of Science, CENTRAL, EMBASE, and Google Scholar) to retrieve all studies that reported the occurrence of IOI following brolucizumab. Data are reported as mean difference with their corresponding 95% confidence intervals. All analyses were conducted per eye, and the risk of bias was assessed using the National Health Institute tool.
Results
Our analysis included 3527 eyes of 3469 patients of 33 papers. The mean age of the patients was 74 years (SD = 10.9, Range = 62.3–80.9). There were 1793 male patients (51.7%) and 1719 female patients (49.6%). The average follow-up period was 13.9 months (SD = 9.4). The mean number of injections was 4.5 (SD = 2.9) injections per eye; 1315 (37.3%) eyes had neovascular AMD, 189 (5.4%) had diabetic macular edema, and 129 (3.7%) eyes had polypoidal choroidal vasculopathy. Post-intervention, subretinal fluid, intraretinal fluid, and pigment epithelial detachment were significantly improved (46.5–11.3% of patients, 55.7–11.3% of patients, 24.7–7.1% of patients, respectively) (p < 0.001). Regarding visual acuity, there was an improvement with a mean difference of 0.12 (95% CI = 0.18–0.07, z = 4.38, p < 0.0001, 2064 eyes). The most common reported complication is IOI (n = 196, 6%). IOI was observed more in the elderly (76.3 ± 9.2 years), females (66%), and after the second injection.
Conclusions
This systematic review provides valuable insights into risk factors and effect modifiers for IOI associated with brolucizumab treatment, aiding clinicians in optimizing patient care. Future studies should prioritize prospective, long-term investigations to further elucidate the safety profile of brolucizumab and refine its use in the management of retinal and choroidal vascular diseases.
PURPOSE
The purpose of this study was to report the visual and anatomic results at 12 and 24 months using the protocol of 3 monthly pro re nata (PRN) injections for diabetic macular edema (DME).
METHODS
This was a retrospective chart review of 97 eyes with DME treated with a protocol of cycles consisting of 3 monthly injections of anti-vascular endothelial growth factor drugs on a PRN basis. Change in visual acuity was the main outcome measure. Macular thickness, number of injections, cycles, and visits in years 1 and 2 of follow-up were secondary outcomes.
RESULTS
Ninety-six patients with a mean age of 60.9 ± 9.96 years were followed for a mean of 22.17 ± 12.30 months. Ninety-two (95.9%), 3 (3%), and 1 (1%) patients were started on bevacizumab, ranibizumab, and aflibercept, respectively. Of bevacizumab patients, 17 (18.2%) were eventually switched to aflibercept. The mean 12-month improvement (standard deviation [SD]) was + 3.3 (17.4) letters (95% confidence interval [CI] = +0.36–+7.05, P < 0.001) after an average (SD) of 5.97 (2.98) injections over a mean (SD) of 1.7 (1.0) three-injection cycles. The mean 24-month improvement (SD) was + 5.6 (13.0) letters (95% CI: −0.28–11.05, P = 0.0186) after an average (SD) of 8.72 (6.31) injections over a mean (SD) of 2.9 (2.1) three-injection cycles. The mean central macular thickness (SD) at baseline, 12 months, and 24 months was 374 ± 120, 322 ± 88, and 305 ± 70 µm. Optical coherence tomography was fluid free at 12 and 24 months in 27.6% and 46% of eyes, respectively.
CONCLUSION
Comparable to real-world studies, this protocol can stabilize or improve vision in more than 85% of DME patients over 24 months. The most important factor in improvement of vision is increasing number of injections and visits.
Background and Objective
This study assesses long-term outcomes following surgical repair of idiopathic full-thickness macular holes (FTMHs) in patients with at least 5 years of postoperative follow-up.
Patients and Methods
A retrospective study evaluated patients diagnosed with idiopathic FTMH who received surgical repair at a single tertiary center with at least 5 years of postoperative follow-up. Data collection included demographic and preoperative characteristics along with macular hole structural integrity as determined by spectral-domain optical coherence tomography (OCT). Functional and structural improvement were assessed by collection of visual acuity and findings on OCT at determined time points until 9 years of follow-up.
Results
The study comprised 90 eyes of 80 patients with a mean age of 67.2 ± 6.8 years, with an average postoperative follow-up of 80.8 ± 17.4 months (range 54 to 130 months). The mean macular hole diameter was 239.7 µm ± 92.2. Macular hole reoperation occurred in four eyes (4%) at a mean duration of 5.5 ± 6 months (range 0.3 to 13 months). Over the study duration, ellipsoid zone (EZ) integrity was maintained in 67.8% of eyes, with an absence of intraretinal fluid (IRF) in 96% on final OCT. The preoperative mean Early Treatment Diabetic Retinopathy Study (ETDRS) best visual acuity (BVA) of 51 improved to a mean BVA of 76 at 5 years postoperatively, with an average gain of 24 letters at one year that remained stable over 5 years ( P < 0.05). Eight years after surgical repair, more than 80% of patients achieved a BVA > 65.
Conclusions
Vitreoretinal surgery for idiopathic FTMH resulted in successful hole closure and sustained visual acuity improvement over long-term follow-up.
[ Ophthalmic Surg Lasers Imaging Retina 2024;55:XX–XX.]
Purpose
To assess macular thickness fluctuations and their association with visual acuity (VA) outcomes in eyes with diabetic macular edema (DME) treated with intravitreal dexamethasone (DEX) implant.
Methods
The standard deviation (SD) of all post-baseline central subfield thicknesses (CST) recorded over a 12-month period after the first injection of DEX implant was used to quantify CST fluctuations. Linear regression models were used to identify factors associated with the VA at 12 months (measured with the Early Treatment of Diabetic Retinopathy Study (ETDRS) score), and predictors of CST SD.
Results
A retrospective review of 80 eyes of 80 patients treated with DEX implant for DME revealed a CST SD of 75.3 ± 50.3 μm. The CST SD was negatively associated with the VA at 12 months (-7.7 EDTRS letters for each 100-µm increase in CST SD, p=0.01), while changes in CST from baseline did not show any significant association. Eyes were stratified into quartiles based on the CST SD and a difference by -14.2 letters in VA at 12 months was observed between the first and fourth quartiles (p <0.001). Significant predictors of CST SD included the baseline VA (-12.0 μm for each 10-letter increase, p=0.02), and the number of DEX injections received (n=17.1, p=0.03).
Conclusion
Greater fluctuations in retinal thickness were found to be associated with poorer visual outcomes in eyes with DME treated with DEX implant. Analyzing the CST SD could be a more predictive indicator of visual prognosis than individual measurements of the CST.
Zusammenfassung
Hintergrund
AURIGA ist die größte prospektive Real-World-Studie zur Behandlung eines Makulaödems (MÖ) nach retinalem Venenverschluss (RVV) oder eines diabetischen Makulaödems mit intravitrealem Aflibercept 2 mg (IVT-AFL). Hier werden die 24-Monats-Daten der deutschen behandlungsnaiven RVV-Kohorte mit MÖ präsentiert.
Methoden
Behandlungsnaive RVV-Patienten mit MÖ wurden mit IVT-AFL 2 mg in der klinischen Routine therapiert. Primärer Endpunkt war die mittlere Änderung des Visus (ETDRS-Buchstaben) zu Monat 12 gegenüber dem Ausgangswert. Die Analyse erfolgte deskriptiv.
Ergebnisse
Es wurden 130 Patienten mit RVV ( n = 61 [46,9 %] mit Zentralvenenverschluss, n = 69 [53,1 %] mit Venenastverschluss) untersucht. Im Mittel (± SD) verblieben die RVV-Patienten für 18,4 ± 7,4 Monate in der Studie. Der mittlere Visusgewinn [95 % Konfidenzintervall] betrug in der Gesamtkohorte +10,9 [7,5; 14,2] Buchstaben zu Monat 12 und +9,7 [6,1; 13,3] zu Monat 24 (Baseline 56,5 ± 18,9 Buchstaben). Nach 24 Monaten hatten 67 % der RVV-Patienten ≥5 Buchstaben, 40 % ≥ 15 Buchstaben gewonnen. Von Baseline betrug die mittlere Injektionszahl 4,4 ± 1,3 bis Monat 6, 6,2 ± 2,7 bis Monat 12 und 8,2 ± 4,5 bis Monat 24. Die durchschnittliche Reduktion der zentralen Netzhautdicke (Ausgangswert 507 ± 177 µm) betrug in der Gesamtkohorte −206 (−252; −160) µm nach 12 Monaten und −219 (−263; −175) µm nach 24 Monaten. Das Sicherheitsprofil entsprach dem früherer Studien.
Diskussion
In der deutschen AURIGA-Kohorte behandlungsnaiver Patienten mit MÖ infolge RVV unter IVT-AFL-2 mg-Behandlung zeigten sich im klinischen Alltag ein rascher und klinisch relevanter Visusgewinn sowie eine Reduktion der zentralen Netzhautdicke. Diese wurden trotz niedriger Injektionsfrequenz ab Monat 6 über 24 Monate weitestgehend erhalten.
Purpose: To evaluate a large database detailing the changes in visual acuity (VA) and central subfield thickness after various treatments for central serous chorioretinopathy (CSCR). Methods: A retrospective analysis was performed of patients with CSCR from January 2015 to September 2022 using the Vestrum Health Retina Database of aggregated de-identified electronic medical records from retina specialists in the United States. The cases of CSCR were categorized by age, sex, and treatment provided. Results: The annual incidence of CSCR was 1.72% (61 755 of 3 598 672 patient eyes), with a mean patient age of 53 years. Male eyes comprised 71.8% of the patient population. Eighty-five percent of patients received no treatment within 1 year of diagnosis. Of the patients needing treatment, 21% received thermal laser therapy, 23% photodynamic therapy, and 49% antivascular endothelial growth factor (anti-VEGF) intraocular injection. Patients not receiving treatment had the best baseline and 1-year VA. All treatment groups had an increased percentage of patients gaining letters compared with patients not receiving treatment. Conclusions: Although most patients did not require treatment, those who received treatment generally did well, with a large proportion having visual gain. Statistical analysis suggests treatment has a positive impact on VA outcomes. Patients receiving combination treatment were older and had the least visual gain of the treated cohorts. Younger patients with CSCR treated with anti-VEGF (and without a secondary diagnosis of macular degeneration) had the greatest increase in VA at 1 year.
Background/aims:
To evaluate the efficacy of intravitreal aflibercept for UME (uveitic macular).
Methods:
A retrospective review of records of patients that received aflibercept for UME from January 2017 to August 2022 was conducted. The primary outcomes were mean change in visual acuity (VA) and central subfield thickness (CST) 6 and 12 months from the start of aflibercept treatment.
Results:
A total of 16 eyes of 12 patients were included. Indications for treatment included eyes that had previously demonstrated a history of elevated intraocular pressure secondary to a steroid response (n = 10) or a history of non-response or partial response to local corticosteroids (n = 6). Fifteen eyes (94%) demonstrated a reduction in CST after their initial injection. At 6-months, mean VA gain was 2.6 ± 7.7 letters (p = 0.24) from a mean VA of 67.8 ± 10.7 letters at baseline and mean CST improved by 97.6 ± 113.5 μm (p = 0.004) from 458.6 ± 123.1 μm at baseline. Fourteen eyes had 12-months of follow up and received a median of 4 injections over 12 visits. The mean VA at 12-months remained stable compared to baseline (mean change of -1.4 ± 12.5 letters (p = 0.87)) while the CST improved by a mean of 90.9 ± 114.6 μm (p = 0.053) compared to baseline.
Conclusion:
Intravitreal aflibercept injections resulted in reduced central subfield thickness at all time-points. It appears to be an effective treatment alternative for UME, particularly for patients who are not responsive to local corticosteroids or who have contraindications to corticosteroid treatment.
Purpose
To review all studies reporting the onset of white dot syndromes following COVID-19 vaccines.
Methods
Our protocol was registered prospectively on PROSPERO [registration number: CRD42023426012]. We searched five different databases including PubMed, Scopus, Web of Science, Google Scholar, and Science Direct up to May 2023. All the studies that reported the occurrence of white dot syndrome following COVID-19 vaccines were included. All statistical tests were conducted with a 95% confidence interval and a 5% error margin. A p value of less than 0.05 was considered statistically significant. The methodological quality of included studies was performed using the IHE Quality Appraisal Checklist for Case Series studies and JBI Critical Appraisal Checklist for Case Reports.
Results
Fifty studies involving seventy-one subjects were included. Multiple evanescent white dot syndrome (MEWDS) was the most common disease (n = 25, 35.2% %), followed by acute macular neuroretinopathy (AMN) (n = 22, 31.0%) and acute posterior multifocal placoid pigment epitheliopathy (APMPPE) (n = 4, 5.6%). They were mostly unilateral (n = 50, 70.4%). The presenting symptoms were blurred vision (n = 26, 36.6%), paracentral scotoma (n = 19, 26.8%), visual field disturbance, and photopsia (n = 7, 9.9%). The mean duration for follow-up was 10.15 ± 14.04 weeks. Nineteen subjects (29.69%) received steroids with improvement reported in 68.4%. Eleven subjects (17.19%) were managed by observation only with reported full recovery and improvement.
Conclusion
White dot syndromes are very rare entities. Our findings highlight a possible association between COVID-19 vaccines and the occurrence of white dot syndromes. However, larger studies with good quality should be implemented to confirm these findings.
Purpose
We used exact matching and inverse propensity score weighting (IPSW) using real-world data (RWD) from the American Academy of Ophthalmology IRIS® Registry (Intelligent Research in Sight) to emulate the 2 pro re nata (prn) treatment arms from the Comparison of AMD Treatment Trial (CATT) and to compare the outcomes of the RWD arms to the 2 monthly treatment arms from the clinical trial.
Design
Retrospective cohort study utilizing deidentified electronic health record registry data and patient-level deidentified clinical trial data.
Subjects
All treatment-naive patient eyes with neovascular age-related macular degeneration treated with ranibizumab or bevacizumab only for 1 year from either the CATT or the IRIS Registry.
Methods
Patients were identified in the IRIS Registry between October 1, 2015 and December 31, 2019. After all nonimaging-based inclusion and exclusion criteria from the CATT were applied, patient eyes receiving bevacizumab or ranibizumab only on a prn basis were identified as the eligible cohort. Exact matching and ISPW was applied based on age, gender, and baseline visual acuity.
Main Outcome Measures
Mean change in visual acuity, in approximated ETDRS letters, between baseline and 1 year for the IRIS Registry prn treatment arms generated by exact matching and IPSW.
Results
We identified 427 eyes treated with ranibizumab prn and 771 eyes treated with bevacizumab prn. Using exact matching, 98% (n = 281) of CATT patient eyes in the bevacizumab monthly treatment arm and 87% (n = 261) of CATT patient eyes in the ranibizumab monthly treatment arm were matched to a patient eye in the IRIS Registry. For the ranibizumab prn treatment arm, patient eyes generated using exact matching gained 1.9 letters and those generated using IPSW gained 2.8 letters (exact matching: 1.9 letters ± 14.0 vs. IPSW: 2.8 letters ± 15.0 letters, P = 0.43). For the bevacizumab prn treatment arm, patient eyes generated using exact matching gained 2.4 letters and those generated using IPSW gained 2.1 letters (exact matching: 2.4 letters ± 15.4 vs. IPSW: 2.1 letters ± 16.0 letters, P = 0.79).
Conclusions
Both exact matching and IPSW produced similar results in emulating the prn treatment arms of the CATT using IRIS Registry data and patient-level clinical trial data. Similar to prior real-world studies, the clinical outcomes were significantly worse in the IRIS Registry treatment arms compared with the clinical trial.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Purpose
To investigate the functional and structural outcomes after treatment with prednisolone eye drops in the following pachychoroid related diseases: chronic central serous chorioretinopathy (cCSC), pachychoroid pigment epitheliopathy (PPE) and peripapillary pachychoroid syndrome (PPS).
Methods
In this retrospective study, 54 eyes of 48 patients with pachychoroid related disease were treated with prednisolone acetate 1% eye drops for 3 times a day. Change in macular volume and retinal central subfield thickness on optical coherence tomography was measured. In addition, foveal or complete resolution of fluid and the change in visual acuity (VA) were studied.
Results
The follow-up visit was at a mean of 41.2 ± 14.5 days. In the 44 eyes with cCSC, a significant reduction in retinal central subfield thickness (p < 0.001) and macular volume (p < 0.001) was observed. Foveal intra- or subretinal fluid resolved completely in 22% of the eyes. In the 8 PPS eyes, a reduction in the nasal retinal thickness was observed (p = 0.025). One of the 2 PPE eyes showed structural improvement. No significant change in VA was observed in any of the pachychoroid spectrum diseases.
Conclusions
In cCSC, PPS and PPE patients, anatomical improvement was observed after therapy with prednisolone eye drops. VA did not change significantly.
Background and Objective
Our aim was to assess long-term outcomes following surgical repair of idiopathic epiretinal membrane (ERM) with pars plana vitrectomy (PPV) and membrane peel (MP).
Patients and Methods
A retrospective study evaluated patients with idiopathic ERM who underwent surgical repair at a single academic tertiary center with five to nine years of postoperative follow-up, assessing preoperative characteristics, surgical techniques, best visual acuity (BVA), and optical coherence tomography biomarkers at various time points.
Results
The study involved 67 patients (72 eyes) with an average postoperative follow-up of 82.8 ± 18.8 months. Patients with cone outer segment tips integrity at initial presentation and 1-year follow-up and patients with external limiting membrane and ellipsoid zone integrity at 1-year follow-up were noted to have significantly better long-term visual acuity than those without. More than 85% of patients achieved a BVA > 70 seven years after surgical repair.
Conclusions
Vitreoretinal surgery for idiopathic ERM resulted in improved anatomical recovery and sustained visual acuity gain over long-term follow-up.
[ Ophthalmic Surg Lasers Imaging Retina 2024;55:XX–XX.]
Purpose: To examine disparities in visual acuity (VA) outcomes 1 year and 2 years after initiation of diabetic retinopathy (DR) or diabetic macular edema (DME) treatment in patients based on race/ethnicity and insurance status, accounting for disease severity. Methods: This retrospective analysis used the IRIS Registry and included DR patients older than 18 years with documented antivascular endothelial growth factor (anti-VEGF) treatment and VA data for at least 2 years. International Classification of Diseases, Tenth Revision, Clinical Modification codes were used to determine the severity of DR and DME presence. VA outcomes were assessed using multivariable linear regressions and anti-VEGF drug use by multivariable logistic regressions, with race and insurance status as independent variables. Main outcome measures comprised the mean VA change at 1 year and 2 years and percentage of patients treated with bevacizumab. Results: Among 43 274 eyes, White patients presented with a higher mean VA and lower mean DR severity than Black and Hispanic patients. Multivariable logistic regression showed Hispanic patients were significantly more likely to be treated with bevacizumab than White patients across all insurance types, controlling for disease severity and VA. After 1 year, the letter improvement was 1.73, 1.33, and 1.13 in White, Black, and Hispanic patients, respectively. Multivariable linear regression suggested that across races, Medicaid-insured patients had significantly smaller gains in VA than privately insured patients. Conclusion: Race-based and insurance-based differences in 1-year and 2-year outcomes after anti-VEGF treatment for DR and anti-VEGF treatment patterns suggest a need to ensure earlier and more effective treatment of minority and underserved patients nationally.
Purpose: To assess the impact of switching to, or adding, an intravitreal dexamethasone implant (Dex; Ozurdex®) in anti-vascular endothelial growth factor (VEGF) therapy on disease stability and treatment intervals in eyes with neovascular age-related macular degeneration (nAMD) and persistent disease activity and high treatment demand. Methods: This retrospective noncomparative multicenter longitudinal case series included pseudophakic eyes with nAMD and persistent retinal fluid despite regular anti-VEGF therapy (ranibizumab or aflibercept) that received at least 1 intravitreal Dex implant. Visual acuity, central retinal thickness (CRT), and intraocular pressure were recorded before, and after, the addition of Dex to anti-VEGF therapy. Results: Sixteen eyes of 16 patients met the inclusion criteria of persistent fluid despite anti-VEGF therapy, under treatment intervals of ≤7 weeks in 14 instances. Patients were 80.9 ± 7.4 years old and had received 25.5 ± 17.4 anti-VEGF injections before Dex over a period of 36.4 ± 21.9 months before switching. The treatment interval increased from 5.5 ± 3.2 weeks between the last anti-VEGF and first Dex injection to 11.7 ± 7.3 weeks thereafter (P = 0.022). CRT remained stable (385.3 ± 152.1, 383.9 ± 129.7, and 458.3 ± 155.2 μm before switching as well as 12 and 24 months after switching; P = 0.78 and P = 0.36, respectively). An insignificant mean short-term early increase in visual acuity was not sustained over time. Conclusions: The addition of Dex resulted in a relevant and sustained increase in treatment intervals, whereas CRT and visual acuity remained stable in these difficult-to-treat eyes. It may be discussed whether inflammation or other steroid-responsive factors play a significant role in cases of nAMD with nonsatisfactory responses to anti-VEGF.
Purpose
Metformin use has been associated with a decreased risk of age-related macular degeneration (AMD) progression in observational studies. We aimed to evaluate the efficacy of oral metformin for slowing geographic atrophy (GA) progression.
Design
Parallel-group, multicenter, randomized phase II clinical trial.
Participants
Participants aged ≥ 55 years without diabetes who had GA from atrophic AMD in ≥ 1 eye.
Methods
We enrolled participants across 12 clinical centers and randomized participants in a 1:1 ratio to receive oral metformin (2000 mg daily) or observation for 18 months. Fundus autofluorescence imaging was obtained at baseline and every 6 months.
Main Outcome Measures
The primary efficacy endpoint was the annualized enlargement rate of the square root-transformed GA area. Secondary endpoints included best-corrected visual acuity (BCVA) and low luminance visual acuity (LLVA) at each visit.
Results
Of 66 enrolled participants, 34 (57 eyes) were randomized to the observation group and 32 (53 eyes) were randomized to the treatment group. The median follow-up duration was 13.9 and 12.6 months in the observation and metformin groups, respectively. The mean ± standard error annualized enlargement rate of square root transformed GA area was 0.35 ± 0.04 mm/year in the observation group and 0.42 ± 0.04 mm/year in the treatment group (risk difference = 0.07 mm/year, 95% confidence interval = −0.05 to 0.18 mm/year; P = 0.26). The mean ± standard error decline in BCVA was 4.8 ± 1.7 letters/year in the observation group and 3.4 ± 1.1 letters/year in the treatment group (P = 0.56). The mean ± standard error decline in LLVA was 7.3 ± 2.5 letters/year in the observation group and 0.8 ± 2.2 letters/year in the treatment group (P = 0.06). Fourteen participants in the metformin group experienced nonserious adverse events related to metformin, with gastrointestinal side effects as the most common. No serious adverse events were attributed to metformin.
Conclusions
The results of this trial as conducted do not support oral metformin having effects on reducing the progression of GA. Additional placebo-controlled trials are needed to explore the role of metformin for AMD, especially for earlier stages of the disease.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
Purpose:
To investigate the efficacy and safety of brolucizumab in diabetic macular edema (DME) and diabetic retinopathy (DR).
Methods:
In this systematic review and meta-analysis, an electronic search was done to acquire all articles describing brolucizumab use in patients with DME and DR. The review was prospectively registered on PROSPERO (CRD42022382625). Collected articles were filtered through two stages by independent reviewers. Data were extracted from the included articles and then analyzed accordingly.
Results:
Brolucizumab induced significant improvement in best-corrected visual acuity and was either better or non-inferior to other types of anti-VEGF (MD -0.64 mu, 95% CI [-1.15, -0.13], P = .01); the same observation was noted with regards to central subfield macular thickness (CSMT) (MD -138.6 mu, 95% CI [-151.9, -125.3], P = .00001). Brolucizumab was reported to be relatively safe for use in diabetic patients, with few adverse events observed, with a higher frequency of adverse events in relation to the 3 mg dose compared to the 6 mg dose.
Conclusion:
Brolucizumab is a new drug that has potential advantages in efficacy over other anti-VEGF agents in the treatment of DME and DR. It showed significant improvement in BCVA and CSMT with the possibility of a lower dosing schedule compared to other agents. Although observed in low frequency, sight-threatening adverse effects appear to occur more frequently compared to other anti-VEGF agents. The main observed adverse event was retinal vasculitis which was seen more commonly with the 3 mg dose versus the 6 mg dose.
Background
To investigate the effect of different sizes of pteryium on the front and back corneal topography, corneal refractive changes and aberrations in natural-light and low-light conditions.
Methods
Sixty subjects with unilateral primary nasal pterygium were enrolled in this study. All the patients’ uncorrected, best spectacle-corrected visual acuities, corneal topographic aberration data in 3mm and 7mm areas were collected. The pterygia sizes were evaluated by the slit-lamp photography and Sirius Scheimpflug Analyzer.
Results
The front topographic astigmatism values, corneal total abbertions, and higher-order aberrations in 3mm and 7mm areas were higher in the pterygia group than those in the control group. The ptergia horizontal length and thickness were moderately to strongly correlated with astigmatism and RMS of aberrations, while pterygia vertical length showed no or just mild correlation with the cornCompared to the readings in 3mm area, the front and back corneal astigmatism and aberrations were larger in 7mm area.
Conclusions
Pterygia led to visual impairment by inducing astigmatism and aberrations. In low-light condition, the visual function were worse because of increased corneal astigmatism values and aberrations.
PURPOSE: To develop a computerized method of visual acuity testing for clinical research as an alternative to the standard Early Treatment for Diabetic Retinopathy Study (ETDRS) testing protocol, and to evaluate its test-retest reliability and concordance with standard ETDRS testing. DESIGN: Test-retest reliability study. METHODS: Multicenter setting of a study population of 265 patients at three clinical sites. Visual acuity was measured with both the electronic visual acuity testing algorithm (E-ETDRS) and standard ETDRS protocol (S-ETDRS) twice on one eye of each patient. E-ETDRS testing was conducted using the electronic visual acuity tester (EVA), which utilizes a programmed Palm (Palm, Inc, Santa Clara, California, USA) hand-held device communicating with a personal computer and 17-inch monitor at a test distance of 3 meters. RESULTS: For the E-ETDRS protocol, test-retest reliability was high (r = 0.99; with 89% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial tests, respectively) and comparable with that of S,ETDRS testing (r = 0.99; with 87% and 98% of retests within 0.1 logMAR and 0.2 logMAR of initial test, respectively). The E-ETDRS and S-ETDRS scores were highly correlated (r = 0.96 for initial tests and r = 0.97 for repeat tests). Based on estimates of 95% confidence intervals, a change in visual acuity of 0.2 logMAR (10 letters) from a baseline level is unlikely to be related to measurement variability using either the E,ETDRS or the S-ETDRS visual acuity testing protocol. CONCLUSIONS: The E-ETDRS protocol has high test-retest reliability and good concordance with S-ETDRS testing. The computerized method has advantages over the S-ETDRS testing in electronically capturing the data for each tested letter, requiring only a single distance for testing from 20/12 to 20/800, potentially reducing testing time, and potentially decreasing technician-related bias.
Objectives:
Assessment of the relationship between visual function and functional status/quality of life in clinical research involving patients with eye disease by investigating whether the scores of four existing functional status/quality of life patient questionnaires are sensitive to differences in visual acuity and studying whether selected subscales of the questionnaires provide similar information concerning the relationship between functional status/quality of life and visual acuity as do the respective full-length questionnaires.Design, Setting, Participants:
Case patients consisted of 86 consecutive patients seen at The Wilmer Ophthalmological Institute Retinal Vascular Center, Baltimore, Md. Controls consisted of 51 individuals with normal visual acuity and no known ocular disease and were frequency-matched to the case patients by age (±5 years), sex, and race. Subjects were interviewed in person using each of the following questionnaires: the Sickness Impact Profile, the vision-specific Sickness Impact Profile, the Community Disability Scale, and the General Health Questionnaire.Results:
Scores of all four questionnaires and their subscales were significantly associated with visual acuity. The vision-specific Sickness Impact Profile and the Community Disability Scale were independently significant predictors of visual acuity. Regression analysis revealed that in our study, selected subscales of the respective full-length questionnaires were able to demonstrate the association between vision and functional status/quality of life.Conclusions:
Ophthalmic patients are at high risk for decreased functional status/quality of life. Subscales of existing questionnaires potentially may be substituted for the full-length questionnaires, thereby increasing the efficiency of functional status/quality of life measurement in such patients.
A more scientific method than the Snellen chart for determining visual acuity is imperative for research studies and is desirable in many clinical situations. The psychometric method using the constant contour interaction S-chart of Flom has been regarded as an accurate and reliable visual acuity measure and has been used widely for research purposes. This paper compares visual acuity measured by the S-chart with that measured by the Snellen and Bailey-Lovie charts. The results indicate that the Baily-Lovie chart is a valid, reliable and rapid method of measuring threshold visual acuity for research purposes.
A standardized visual acuity technique is presented for use in anti-cataract drug trials. Ferris Logmar charts were used in repeatability studies of vision, visual acuity and pinhole visual acuity measurements for twenty normal subjects (mean (±SD) age 64 ± 6.3 years). Visual acuity measurements were shown to be the most repeatable and thought to be the most suitable for monitoring cataract progression. Repeated visual acuity measurements were made on 29 cataractous eyes of 15 subjects (mean (±SD) age 67.8 ± 7.2 years). A Logmar score change of 0.1 (one line) was shown to be a statistically significant change. This value can be used in statistical analyses of drug efficacy. The normal data gives a mean Logmar visual acuity of 1.15 (Snellen equivalent 6/5). This indicates the inadequacy of using 6/6 as a norm value for visual acuity, even for older patients. As the possibility of reversal of cataract theoretically exists in the early stages of cortical and capsular cataracts, patients with small amounts of these types of cataract are ideal patients for anti-cataract formulation trials. The normal visual acuity results indicate that the inclusion criteria for clinical trials can include patients with cataracts with visual acuity as good as 6/6.
This paper intoduces new principles for the design and use of letter charts for the measurement of visual acuity. It is advocated that the test task should be essentially the same at each size level on the chart. Such standardization of the test task requires the use of letters of equal legibility, the same number of letters on each row, and uniform between-letter and between-row spacing. It is also advocated that, combined with the test task standardization, there should be a logarithmic progression of letter size. Charts incorporating these design features have been made. These charts facilitate the use of nonstandard testing distances which might be used when there is low visual acuity, when examination room layout prevents testing at the standard distance, or when it is necessary to validate visual acuity scores or detect malingering. Adjusting the visual acuity score according to the chosen testing distance is simplified by the use of logarithmic scaling.
A standardized visual acuity technique is presented for use in anti-cataract drug trials. Ferris Logmar charts were used in repeatability studies of vision, visual acuity and pinhole visual acuity measurements for twenty normal subjects (mean (+/- SD) age 64 +/- 6.3 years). Visual acuity measurements were shown to be the most repeatable and thought to be the most suitable for monitoring cataract progression. Repeated visual acuity measurements were made on 29 cataractous eyes of 15 subjects (mean (+/- SD) age 67.8 +/- 7.2 years). A Logmar score change of 0.1 (one line) was shown to be a statistically significant change. This value can be used in statistical analyses of drug efficacy. The normal data gives a mean Logmar visual acuity of 1.15 (Snellen equivalent 6/5). This indicates the inadequacy of using 6/6 as a norm value for visual acuity, even for older patients. As the possibility of reversal of cataract theoretically exists in the early stages of cortical and capsular cataracts, patients with small amounts of these types of cataract are ideal patients for anti-cataract formulation trials. The normal visual acuity results indicate that the inclusion criteria for clinical trials can include patients with cataracts with visual acuity as good as 6/6.
A standard Snellen chart and a chart that controls contour interaction effects and gives equal numbers of acuity trials for all letter sizes (the S-chart) were used to compare visual acuities for 30 amblyopic patients (17 with central fixation, 13 with eccentric fixation). No statistically significant difference appeared between S-chart and Snellen acuity in the acuity range 20/30 to 20/80. When amblyopic acuity was below 20/100, S-chart and Snellen acuities differed significantly.
We have designed two boxes, one using direct illumination and the other using retroillumination, to light high-contrast visual acuity charts during testing. The evenness of the lighting eliminated one of the variables in visual acuity testing.
Three new visual acuity charts facilitate quantitative use of visual acuity test results. The charts have high-contrast lettering on washable white polystyrene. Each line has five Sloan letters; the lines are of equal difficulty and there is a geometric progression in letter size from line to line. This provides a similar task for each line on the chart with the letter size being the only variable. Charts with different letter sequences are used for testing right and left eyes.
Data collected by clinicians and nurses from patients with clinically diagnosed lens opacities revealed that there was poor repeatability of the description of the position of lens opacities, statistically significant observer variation in determining visual acuity, and good repeatability as to what visual tasks the patient can perform. It is suggested that clinicans should give more weight to the visual handicap revealed by performance of visual tasks in making a decision for cataract surgery than at present.
Despite its critical importance to our daily life, the most common measurement of visual function, visual acuity, is a relatively crude and narrow one testing only a small portion of the broad range of visual functions. Visual acuity is the measurement of the ability to discriminate two stimuli separated in space at high contrast relative to the background. Clinically, this is measured by asking the subject to discriminate letters of known visual angle. The visual acuity is represented as the reciprocal of the minimal angle of resolution (the smallest letters resolved) at a given distance and at high contrast. Other measurements of visual acuity also exist, including Vernier acuity. Newer charts, such as the ETDRS chart, use letters of equal recognition difficulty and use the log of the minimal angle of resolution; these charts have significant advantages over the old Snellen-type charts. This article reviews visual measurements in children and in patients with low vision, and it reviews factors affecting visual acuity, such as pupil size, refractive error, media opacities, and pharmacologic agents.
To describe visual acuity (VA) testing and scoring methods used in multicenter randomized clinical trials in ophthalmology in the United States (USA) sponsored by the National Eye Institute (NEI).
A survey was conducted among multicenter studies in the US that included one or more randomized clinical trials and were sponsored by the NEI, National Institutes of Health. To be included in the survey, a study had to have VA reported in one or more publications or patient eligibility based on VA, a majority of study subjects 13 years of age or older, and a patient population primarily or exclusively from the US. A standard survey form was completed for each study based on information presented in the study manual of procedures and publications. Findings were summarized and displayed with frequency distributions.
The survey included 24 studies, each with enrollment initiated in the period 1972 to 1999. VA was one of the study eligibility criteria for 19 (79%) studies, and VA or change in VA was the primary outcome in 12 (50%) studies. ETDRS charts have been employed in 16 of 19 studies initiated after the charts were published in 1982. All studies but one specified in the documents reviewed that VA testing was performed at multiple VA test distances. For studies that used ETDRS charts, methods of converting VA scores obtained at different test distances to a common scale fell into two categories: 11 studies used a method similar in nature to that first reported in the Macular Photocoagulation Study, and 7 studies used a method similar in nature to that first reported in the Krypton-Argon Regression of Neovascularization Study. conclusion The development of the ETDRS charts and a custom light box has led to more uniformity in VA test charts and chart illumination. However, details of VA measurement protocols vary widely from study to study. To assure comparable data across studies and ocular conditions, it would be useful to have a standard VA testing and scoring protocol with provisions for testing different levels of visual acuity that recommends a single method for converting scores from different test distances to a common scale and standard conversion of "off the chart" VA levels for calculation of means and changes in VA.
Several committees of the A.M.A. have, in the past, made recommendations pertaining to the specification of charts for testing visual acuity: 1. 1. In 1916 and again in 1930 it was recommended that, for testing literate subjects, letters be used which are of known difficulty in comparison with the Landolt ring. 2. 2. In 1953 a Committee on Optotypes recommended that letter sizes be designated in terms of the visual angle in minutes of arc subtended by the component parts. 3. 3. This committee and previous ones recommended a geometric progression in letter sizes, that is, equal steps on a logarithmic scale. The charts described in this report for testing acuities at 20 feet and at a near distance fulfill all of the above recommendations. A special set of 10 letters is employed for testing literate subjects. These have been shown to give measures of visual acuity closely equal to those obtained with Landolt rings. For testing illiterate subjects, Landolt rings with breaks in horizontal and vertical locations are substituted for letters. Eleven sizes of optotype between 1.0 minute ( 20 20) and 10 minutes ( 20 200) are provided for testing at 20 feet and at a near distance. The chart for use at a near distance has in addition two sizes larger than 10 minutes. At distance these larger visual angles are obtained by a decrease in testing distance. Additional letters and rings are provided on laminated cards for convenient use at distances shorter than 20 feet. The charts for testing visual acuity at a near distance include alternate forms for use at standard distances of 14 and 16 inches (35 and 40 cm.). It is recommended by this subcommittee that 40 cm. be adopted as the standard for testing visual acuity at a near distance.
Visual acuity (VA) is the primary outcome measure in many studies involving eye diseases. A standard statistical approach for comparing a continuous measurement such as a VA letter score between 2 treatment groups is to perform a t test comparing the means. However, frequently a binary variable is created from the continuous VA letter score based on whether or not there has been a worsening (or gain) of > or =15 letters (equivalent to > or =3 lines), and a chi square or similar statistical test is performed to compare the proportions of success (or failure) between groups. The purpose of this article is to contrast these 2 approaches.
Clinical trial reports of retinal disorders were used to compare results using mean change in the VA letter score versus binary proportions created from the VA letter score. Additionally, analyses were performed using generated data to gain a perspective on the magnitude of differences that might be expected between the 2 methods.
Studies from the literature showed that differences of 6% to 15% in > or =15-letter worsening corresponded to mean differences in letter scores between groups of 3.0 to 7.0 (approximately 0.6 to 1.4 lines). Analyses using generated data demonstrated that a mean improvement in the VA letter score of 5 corresponded to a doubling of the proportion of eyes with > or =15-letter improvement and a 28% relative reduction in the proportion of eyes with > or =15-letter worsening.
How VA data should be analyzed in a clinical trial depends to large extent on the research question. The frequently used outcome of > or =15-letter change has several drawbacks, including loss of efficiency (need for a larger sample), misclassification of the outcome, and potential for a ceiling or floor effect. Therefore, for most clinical trials we believe that the primary outcome analysis should be a comparison of changes in the VA letter score, and created binary variables should be reported as secondary outcomes. This approach maximizes the information gained from the data and accommodates both improvement and worsening of acuity.