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Is ellipsoid zone integrity essential for visual recovery in myopic neovascularization after anti-VEGF therapy?

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Paolo Milani at I.R.C.C.S. Istituto Auxologico Italiano
Paolo Milani
Marco Pellegrini
Marco Pellegrini
Marco Pellegrini
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Amedeo Massacesi
Amedeo Massacesi
Amedeo Massacesi
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Stefania Moschini
Stefania Moschini
Stefania Moschini
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Abstract and Figures

Purpose: To evaluate functional prognostic factors and neuroretinal changes after anti-vascular endothelial growth factor (VEGF) treatment in patients with naïve, recent myopic neovascularization (mCNV), as assessed by spectral-domain optical coherence tomography (SD-OCT). Methods: Specific changes in tomographic features between baseline and final follow-up were retrospectively evaluated by two examiners independently. Imaging was obtained by a multi-modal imaging system which combines fluorescein angiography and SD-OCT. Results: Twenty-two eyes (male, six; female, 16; mean age, 65 ± 14 years) were considered. Mean follow-up was 21.5 ± 14 months. Best-corrected visual acuity (BCVA) improved from 0.38 ± 0.26 to 0.16 ± 0.20 logMAR (p < 0.001). The ellipsoid zone and the external limiting membrane (ELM) were disrupted in 21 (95.5%) and 15 (68.2%) eyes at baseline, and in 16 (72.7%) and nine (40.9%) eyes after therapy respectively. The ellipsoid zone and ELM were typically intact at lesion margins in 13 (59.1%) and 19 eyes (86.5%) respectively at baseline. The inner retina was intact in 20 eyes (91%). Six eyes (27.3%) exhibited complete regression without fibrosis. Absence of hemorrhage and integrity of lesion-adjacent ELM and of lesion-adjacent ellipsoid zone at baseline were factors for better final BCVA (p ≤ 0.05) CONCLUSION: Vision gain might occur despite ellipsoid zone or ELM restoration. Hemorrhage could be considered a negative prognostic factor, integrity of lesion-adjacent ELM and of lesion-adjacent ellipsoid zone as positive prognostic factors. Myopic CNV can also resolve completely without fibrosis.
Spectral-domain optical coherence tomography imaging of myopic neovascularization (mCNV) in three patients before (baseline; top row) and after (bottom row) intravitreal anti-vascular endothelial growth factor (VEGF) therapy. Patient 1: a 49-year-old patient exhibited a typical foveal hyper-reflective area (red arrow) above the retinal pigment epithelium (RPE) band, with a fuzzy area on the top, small retinal fluid cysts, epiretinal membrane (ERM), and some serous neuroretinal detachment (SND). While the ellipsoid zone and external limiting membrane (ELM) were absent at baseline, the outer nuclear layer (ONL) and other inner segments were present (white circle). Eighteen months after the fifth anti-VEGF injection, the fuzzy area had resolved; the ellipsoid zone and the ELM adjacent to the lesion had reformed (blue triangle and yellow asterisk respectively). In correspondence of the fibrosis, the examiners disagreed about the reconstitution of the ELM. The lesion was then considered to be included in the RPE. The initial and final best-corrected visual acuities (BCVA) were 0.4 and 0.1 logarithm of the minimum angle of resolution (log MAR). Patient 2: the patient presented with mCNV, a fuzzy area (red arrow) and hyper-reflective foci (HF) but no edema at baseline, when the BCVA was 0.4 logMAR. The ellipsoid segment and ELM were absent in correspondence to the lesion. Integrity of the ONL and external plexiform layer (EPL) was doubtful. The inner segments of the retina were spared (white circle). Twenty-nine months after the third intravitreal anti-VEGF injection, the ellipsoid zone and the ELM were restored adjacent to the lesion (blue triangle and yellow asterisk respectively). The BCVA had stabilized at 0.2 log MAR, and fibrosis was complete. The lesion was located inside the thickened RPE band and the HF were found to have resolved. Patient 3: this 49-year-old patient presented with a hyper-reflective area (red arrow) above the RPE, with a fuzzy area but no fluid at baseline. The BCVA was 0.4 log MAR. Only the lesion-adjacent ELM could be visualized (yellow asterisk), along with the EPL and other inner segments. Twelve months after the second intravitreal anti-VEGF injection), BCVA had improved to 0.2 log MAR although the ellipsoid segment had not been restored. Fibrosis was complete, and the lesion, which was initially above the RPE, was now located inside the RPE band
Spectral-domain optical coherence tomography imaging of myopic neovascularization (mCNV) in three patients before (baseline; top row) and after (bottom row) intravitreal anti-vascular endothelial growth factor (VEGF) therapy. Patient 1: a 49-year-old patient exhibited a typical foveal hyper-reflective area (red arrow) above the retinal pigment epithelium (RPE) band, with a fuzzy area on the top, small retinal fluid cysts, epiretinal membrane (ERM), and some serous neuroretinal detachment (SND). While the ellipsoid zone and external limiting membrane (ELM) were absent at baseline, the outer nuclear layer (ONL) and other inner segments were present (white circle). Eighteen months after the fifth anti-VEGF injection, the fuzzy area had resolved; the ellipsoid zone and the ELM adjacent to the lesion had reformed (blue triangle and yellow asterisk respectively). In correspondence of the fibrosis, the examiners disagreed about the reconstitution of the ELM. The lesion was then considered to be included in the RPE. The initial and final best-corrected visual acuities (BCVA) were 0.4 and 0.1 logarithm of the minimum angle of resolution (log MAR). Patient 2: the patient presented with mCNV, a fuzzy area (red arrow) and hyper-reflective foci (HF) but no edema at baseline, when the BCVA was 0.4 logMAR. The ellipsoid segment and ELM were absent in correspondence to the lesion. Integrity of the ONL and external plexiform layer (EPL) was doubtful. The inner segments of the retina were spared (white circle). Twenty-nine months after the third intravitreal anti-VEGF injection, the ellipsoid zone and the ELM were restored adjacent to the lesion (blue triangle and yellow asterisk respectively). The BCVA had stabilized at 0.2 log MAR, and fibrosis was complete. The lesion was located inside the thickened RPE band and the HF were found to have resolved. Patient 3: this 49-year-old patient presented with a hyper-reflective area (red arrow) above the RPE, with a fuzzy area but no fluid at baseline. The BCVA was 0.4 log MAR. Only the lesion-adjacent ELM could be visualized (yellow asterisk), along with the EPL and other inner segments. Twelve months after the second intravitreal anti-VEGF injection), BCVA had improved to 0.2 log MAR although the ellipsoid segment had not been restored. Fibrosis was complete, and the lesion, which was initially above the RPE, was now located inside the RPE band
… 
Spectral-domain optical coherence tomography imaging and fluorescein angiography of myopic neovascularization (mCNV) in two patients before (baseline; top row) and after (bottom row) intravitreal anti-vascular endothelial growth factor (VEGF) therapy. Patient 4: this eye presented a hyper-reflective lesion with a fuzzy area (4top, red arrow) above the retinal pigment epithelium (RPE), involving the ellipsoid zone, external limiting membrane (ELM), external plexiform layer (EPL), and outer nuclear layer (ONL). Only the inner part of the retina was spared (white circle). On fluorescein angiography (4 fa. top) a clearly visible leakage is evident in correspondence to the mCNV (red arrow). After the third intravitreal anti-VEGF injection, the leakage resolved (4 fa. bottom, red arrow), the hyper-reflective area disappeared completely (4 bottom, red arrow), and the best-corrected visual acuity (BCVA) had improved from 0.4 at baseline to 0.2 logarithm of the minimum angle of resolution(log MAR), although absence of the ellipsoid zone and ELM persisted even at 16 months post-treatment. Patient 5: in this 43-year-old patient, a newly detected foveal mCNV (5 top, red arrow) had spread above the RPE band, which appeared intact. The ellipsoid zone, ELM, ONL, and EPL had lost their integrity at the location of the lesion. Only the presence of an intact inner retina could be assessed (white circle). On fluorescein angiography (5 fa. top) some leakage is detectable from the lesion that disappeared after the second anti-VEGF injection (5 fa. bottom), when the mCNV resolved completely (5 bottom, red arrow), and all neuroretinal layers were restored (yellow asterisk: ELM. blue triangle: ellipsoid zone). The BCVA had increased from 0.3 to 0 log MAR, and no recurrences were observed over a 25-month follow-up period
Spectral-domain optical coherence tomography imaging and fluorescein angiography of myopic neovascularization (mCNV) in two patients before (baseline; top row) and after (bottom row) intravitreal anti-vascular endothelial growth factor (VEGF) therapy. Patient 4: this eye presented a hyper-reflective lesion with a fuzzy area (4top, red arrow) above the retinal pigment epithelium (RPE), involving the ellipsoid zone, external limiting membrane (ELM), external plexiform layer (EPL), and outer nuclear layer (ONL). Only the inner part of the retina was spared (white circle). On fluorescein angiography (4 fa. top) a clearly visible leakage is evident in correspondence to the mCNV (red arrow). After the third intravitreal anti-VEGF injection, the leakage resolved (4 fa. bottom, red arrow), the hyper-reflective area disappeared completely (4 bottom, red arrow), and the best-corrected visual acuity (BCVA) had improved from 0.4 at baseline to 0.2 logarithm of the minimum angle of resolution(log MAR), although absence of the ellipsoid zone and ELM persisted even at 16 months post-treatment. Patient 5: in this 43-year-old patient, a newly detected foveal mCNV (5 top, red arrow) had spread above the RPE band, which appeared intact. The ellipsoid zone, ELM, ONL, and EPL had lost their integrity at the location of the lesion. Only the presence of an intact inner retina could be assessed (white circle). On fluorescein angiography (5 fa. top) some leakage is detectable from the lesion that disappeared after the second anti-VEGF injection (5 fa. bottom), when the mCNV resolved completely (5 bottom, red arrow), and all neuroretinal layers were restored (yellow asterisk: ELM. blue triangle: ellipsoid zone). The BCVA had increased from 0.3 to 0 log MAR, and no recurrences were observed over a 25-month follow-up period
… 
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RETINAL DISORDERS
Is ellipsoid zone integrity essential for visual recovery in myopic
neovascularization after anti-VEGF therapy?
Paolo Milani
1
&Marco Pellegrini
2
&Amedeo Massacesi
1
&Stefania Moschini
1
&
Marco Setaccioli
1
&Davide Soranna
3
&Antonella Zambon
3
&Ferdinando Bottoni
2
&
Fulvio Bergamini
1
Received: 3 March 2017 /Revised: 15 May 2017 / Accepted: 30 May 2017 /Published online: 30 June 2017
#Springer-Verlag Berlin Heidelberg 2017
Abstract
Purpose To evaluate functional prognostic factors and
neuroretinal changes after anti-vascular endothelial growth
factor (VEGF) treatment in patients with naïve, recent myopic
neovascularization (mCNV), as assessed by spectral-domain
optical coherence tomography (SD-OCT).
Methods Specific changes in tomographic features between
baseline and final follow-up were retrospectively evaluated
by two examiners independently. Imaging was obtained by a
multi-modal imaging system which combines fluorescein an-
giography and SD-OCT.
Results Twenty-two eyes (male, six; female, 16; mean age,
65 ± 14 years) were considered. Mean follow-up was
21.5 ± 14 months. Best-corrected visual acuity (BCVA) im-
proved from 0.38 ± 0.26 to 0.16 ± 0.20 logMAR (p<0.001).
The ellipsoid zone and the external limiting membrane (ELM)
were disrupted in 21 (95.5%) and 15 (68.2%) eyes at baseline,
and in 16 (72.7%) and nine (40.9%) eyes after therapy respec-
tively. The ellipsoid zone and ELM were typically intact at
lesion margins in 13 (59.1%) and 19 eyes (86.5%) respectively
at baseline. The inner retina was intact in 20 eyes (91%). Six
eyes (27.3%) exhibited complete regression without fibrosis.
Absence of hemorrhage and integrity of lesion-adjacent ELM
and of lesion-adjacent ellipsoid zone at baseline were factors
forbetterfinalBCVA(p≤0.05)
Conclusion Vision gain might occur despite ellipsoid zone or
ELM restoration. Hemorrhage could be considered a negative
prognostic factor, integrity of lesion-adjacent ELM and of
lesion-adjacent ellipsoid zone as positive prognostic factors.
Myopic CNV can also resolve completely without fibrosis.
Keywords Myopic neovascularization .Pathologic myopia .
Neuroretina .Fluorescein angiography .SD-OCT .Optical
coherence tomography .Anti-VEGF .Myopia .External
limiting membrane .Ellipsoid zone
Introduction
Myopic choroidal neovascularization (mCNV) is a classic
type 2 lesion [1] with a neovascular network spreading from
the choriocapillaris through the retinal pigment epithelium
(RPE) towards the neuroretina. In comparison with neovascu-
larization associated with age-related macular degeneration
(AMD), mCNVexhibits unique features on fluorescein angi-
ography (FA) and spectral-domain optical coherence tomog-
raphy (SD-OCT) [2] and typically requires fewer treatments
[3]. It has been reported that 5.2–11.3% of subjects with high
myopia develop mCNV [4], which usually presents good
prognosis after intravitreal anti-vascular endothelial growth
factor (VEGF) therapy [5–7].
Several descriptions of the tomographic features of naïve
mCNV exist in literature [8–11]. Naïve mCNV usually pre-
sents as a small lesion, with infrequent hemorrhage and retinal
fluid accumulation. It may be visualized as a hyper-reflective
lesion above the RPE, mainly involving the external segments
of the retina and causing a corresponding retinal thickening.
However, macular neuroretinal layers changes following anti-
*Paolo Milani
dottpaolomilani@hotmail.com
1
Ophthalmology Department, Istituto Auxologico Italiano, ViaStefini
10, 20125 Milan, Italy
2
Eye Clinic, Biomedical and Clinical Sciences Department, Luigi
Sacco Hospital, University of Milan, Milan, Italy
3
Statistics and Quantitative Methods Department, University of
Milano-Bicocca and Istituto Auxologico Italiano, Milan, Italy
Graefes Arch Clin Exp Ophthalmol (2017) 255:1713–1720
DOI 10.1007/s00417-017-3706-x
Content courtesy of Springer Nature, terms of use apply. Rights reserved.
... In clinical practice, the fuzzy area is recognized as the prominent active mCNV biomarker, forming part of the subretinal hyperreflective exudation that is a pathognomonic sign of activity [4]. Originally described by Introini [3], it has a reported sensitivity ranging from 84.6-95.5% [3,9,[15][16][17]; in contrast, the lower prevalence in our study (67.4%) suggests that mCNV may be active independent of the fuzzy area. Furthermore, a good but not high interobserver agreement (k = 0.76) recommends caution when considering this parameter. ...
... Signs of exudation, such as IRF and SRF, had relatively low prevalences in our study (40 of 83 active mCNV cases; 48.1%) similar to other recent reports (43.4-56%) [9,11,16,17]. Interestingly, since IRF was present in nine of the 39 controls (23%), we suggest excluding this indicator alone for intravitreal treatment, especially in long-standing lesions. ...
... In the last years, HF have been investigated in macular diseases as a sign of edema and inflammation [24,25]. We originally described the HF prevalence in mCNV as 40.9% and 0% before and after intravitreal treatment, respectively [17]. The present larger study confirmed a similar prevalence at baseline, although HF also occurred frequently in the control group (42.1% and 23%, respectively). ...
Algorithm of the major and minor diagnostic criteria for active myopic choroidal neovascularization
Article
Full-text available
  • Apr 2022
  • GRAEF ARCH CLIN EXP
Purpose To propose an algorithm of the major and minor diagnostic criteria for macular myopic choroidal neovascularization (mCNV). Methods This single-center, retrospective, cross-sectional study was based in Istituto Auxologico Italiano, Milan, Italy. Two authors evaluated the clinical and imaging parameters of eyes with high myopia (spherical equivalent of -6D or less) and suspected to have naïve, recurrent, or inactive mCNV. Recordings of the eyes that met the inclusion criteria were then independently evaluated by two other senior retinal specialists. Fluorescein angiography (FA), spectral domain optical coherence tomography (SD-OCT), and OCT angiography were used for multimodal imaging. Results One-hundred and twenty-two eyes (n = 107; 39 men, 68 women) were included in the study. The mean patient age was 66 years (range, 22–89 years). There were 83 and 39 eyes in the active mCNV and control groups, respectively. The best diagnostic algorithm had positive- and negative-predictive values of 89% and 85%, respectively, and was based on four criteria: leakage/staining on FA, retinal thickening, fuzzy area on SD-OCT, and recent metamorphopsia. When excluding FA-derived findings, retinal pigment epithelium (RPE) features played a diagnostic role in 33 eyes (27%). Twenty-seven eyes with active mCNV (32%) did not have the fuzzy area. Taken singularly, no clinical or imaging parameter had both sensitivity and specificity greater than 78%. Matching of 2 or 3 biomarkers did not yield a sensitivity or specificity greater than 79%. Sensitivities and specificities ≥ 90% were found in ten criteria combinations that included four to five biomarkers. The most frequent were metamorphopsia, fuzzy area, retinal thickening, and leakage. Less frequently, they included hemorrhage, staining, and RPE features such as elevation, flattening, and focal interruption. For all the parameters, the agreement between the investigators was good (Cohen k ≥ 0.66), being the lowest when detecting the ELM interruption within the lesion. Conclusions A combination of at least four clinical and biological markers yielded the highest positive- and negative-predictive values. More (“major”) and less (“minor”) frequent diagnostic criteria are proposed.
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... It has been reported that younger patients and those with favorable indocyanine green findings (a dark rim) and favorable OCT findings (integrity of the lesion-adjacent external limiting membrane and the lesion-adjacent ellipsoid zone) have a good prognosis, while those with hemorrhage have a poor prognosis. 40,41 Furthermore, a dome-shaped macula was reported not to be a negative prognostic factor in response to anti-VEGF therapy in mCNV after 2 years. However, in eyes with a dome-shaped macula, mCNV tends to be extrafoveal, thus ensuring a good visual prognosis from the earliest stage of the disease. ...
Systemic Oxidative Stress Level as a Pathological and Prognostic Factor in Myopic Choroidal Neovascularization
Article
Full-text available
  • May 2024
Purpose To investigate the association of systemic oxidative stress level with myopic choroidal neovascularization (mCNV) and its clinical outcomes. Design Retrospective case-control study. Participants This retrospective study included 52 eyes of 52 healthy participants (mean age: 62.5 years), 30 eyes of 30 patients (mean age: 59.6 years) with high myopia (HM) but without mCNV, and 23 eyes of 23 patients (mean age: 61.8 years) with HM and mCNV who received intravitreal anti-VEGF antibody injections (IVIs) using a pro re nata regimen during the 6-month follow-up after the first IVI. Methods Clinical findings, including oxidative stress parameters, such as diacron reactive oxygen metabolites (dROMs), biological antioxidant potential (BAP), and the BAP/dROM ratio (B/d ratio), were analyzed. Main Outcome Measures Clinical features and oxidative stress parameters. Results Both BAP and the B/d ratio were significantly lower in the HM/mCNV group than in the HM/no mCNV group (P = 0.002 and P = 0.012, respectively) and than in the control group (P = 0.001 and P = 0.026, respectively). In a multiple logistic regression analysis, axial length (odds ratio 1.878, P = 0.042) and the B/d ratio (odds ratio 0.470, P = 0.026) were significantly associated with mCNV. Dividing the patients into high and low B/d ratio groups (with a cutoff of 5.2) showed that subfoveal choroidal thickness (SFCT) was lower (P = 0.002) and the number of IVI treatments was higher (P = 0.029) in the low B/d ratio group than in the high B/d ratio group. In multiple regression analyses, only the B/d ratio was significantly associated with SFCT (β = 0.684, P = 0.006). Conclusions The oxidative stress level in eyes with HM differed according to mCNV, SFCT, and the number of IVI treatments. Measuring oxidative stress parameters might be useful in eyes with HM both for assessing the risk of developing mCNV and determining disease activity. Financial Disclosure(s) Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
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... This was consistent with previous studies finding a BCVA correlation in EZ structural integrity (18,(20)(21)(22)(23). However, it is not consistent with Milani's view (24). He found that even in absence of EZ at baseline and final follow-up, it was observed to be increased BCVA. ...
Factors associated with the recurrence of choroidal neovascularization in pathologic myopia
Article
Full-text available
  • Sep 2022
Purpose To investigate the factors associated with the recurrence of pathologic myopia choroidal neovascularization (PM-CNV). Methods Forty-eight eyes of 48 patients with PM-CNV treated with conbercept at least 6 months of follow-up were included. Appearance of ellipsoid zone (EZ) and retinal pigment epithelium (RPE) observed on optical coherence tomography (OCT). Hyperreflective foci (HRF) height measured on OCT. Observation of CNV shape on OCT-angiography (OCTA). PM-CNV area measured on OCTA. To observe relationship between these factors and best corrected visual acuity (BCVA) and PM-CNV recurrence. Results The 48 patients (48 eyes) with PM-CNV were divided into two groups: yielding a group of 20 eyes with type 1 and a group of 28 eyes with type 2. The BCVA of type 1 was better than type 2 before and after treatment ( P < 0.005). Smaller HRF height ( P < 0.001) and CNV area ( P < 0.001) for type 1 than type 2. The appearance of EZ and RPE were intact ( P < 0.001). Spearman correlation analysis found that final BCVA was significantly associated with baseline BCVA, HRF height, and appearance of EZ ( P < 0.05). Binary logistics regression analysis revealed that PM-CNV recurrence was significantly correlated not only HRF height and CNV area, but also with appearance of EZ, and RPE ( P < 0.05). Conclusion PM-CNV had a higher recurrence ratio. Baseline BCVA and clinical features play an important role for vision prognosis. Factors associated with PM-CNV recurrence include HRF height, CNV area, and changes in EZ and RPE structure.
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... Qualitative assessment of outer retinal integrity via measurement of the ellipsoid zone and ELM on OCT is potentially of significant value because their integrity has been regarded as a consistent biomarker for visual acuity 27 . Milani et al. 28 inferred that the integrity of the ellipsoid zone at baseline was a positive predictive factor for final visual acuity after anti-VEGF treatment in patients with mCNV. Similarly, a better inner/outer segment line and ELM integrity showed a significant positive effect on BCVA outcome in a prospective study 14 . ...
Baseline predictors for good visual gains after anti-vascular endothelial growth factor therapy for myopic choroidal neovascularization
Article
Full-text available
  • Apr 2022
To investigate optical coherence tomography (OCT) and OCT angiography (OCTA) biomarkers for good visual outcomes in eyes with myopic choroidal neovascularization (mCNV) following anti-vascular endothelial growth factor (anti-VEGF) therapy. Patients diagnosed with mCNV via multimodal imaging were retrospectively reviewed. Baseline demographic data and biomarkers were collected. Anti-VEGF treatment based on a pro re nata (PRN) regimen was conducted on all eyes. The visual gains of ≥ 15 ETDRS letters or < 15 letters at 12-month were classified into two groups. Regression analysis was used to identify variables associated with significant best-corrected visual acuity (BCVA) improvement. Among 34 patients, 17 eyes and 17 eyes were classified into the two groups. There were no statistically significant differences in qualitative OCTA biomarkers between the two groups. The ≥ 15 letters group had significantly thicker subfoveal choroid thickness (SFCT) (79.97 ± 33.15 vs. 50.66 ± 18.31, P = 0.003), more ellipsoid zone integrity (58.8% vs. 23.5%, P = 0.037) and lower levels of fractal dimension (1.45 ± 0.101 vs. 1.53 ± 0.082, P = 0.031) than the < 15 letters group. SFCT and the ellipsoid zone integrity were correlated with 15 letters or more VA improvement in both univariable and multivariable analyses (P = 0.023 and P = 0.044, respectively). Thicker SFCT and integrity of the ellipsoid zone at baseline were associated with greater visual gains at 12 months. OCTA biomarkers seem to play a less important role in predicting the visual outcome of mCNV.
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... However, it is still controversial. In the study reported by Paolo Milani et al 21 , it was unlikely that lesion activity was correlated solely to ELM disruption and vision gain might occur despite ellipsoid zone or ELM restoration. In addition to obscuring optical reflectivity by active CNV at the level of the ELM on OCT imaging, absence of ELM visibility could be ascribed to ELM disruption which indicated an irreversible damage of the photoreceptors 18 . ...
Baseline characteristics of myopic choroidal neovascularization in patients above 50 years old and prognostic factors after intravitreal conbercept treatment
Article
Full-text available
  • Apr 2021
To investigate the influence of age on the function and morphology of patients with myopic choroidal neovascularization (mCNV) and to evaluate the effect and prognostic factors of recurrence of Conbercept treatment on mCNV patients over 50 years. A total of 64 patients (64 eyes) with mCNV were enrolled in this retrospective study. The differences in baseline best-corrected visual acuity (BCVA) and morphological features on imaging between the younger group (˂ 50 years) and the older group (≥ 50 years) were analyzed. Of all, 21 eyes of 21 mCNV patients aged over 50 years who received Conbercept injection were further analyzed. Between the younger and the older group, significant differences were shown in mean BCVA (0.58 ± 0.28 vs 0.77 ± 0.31), subfoveal choroidal thickness (SFCT) (108.17 ± 78.32 μm vs 54.68 ± 39.03 μm) and frequency of vitreoretinal interface abnormalities (VIA) (2 vs 13), respectively (P < 0.05). After treated with Conbercept, the mean BCVA of 21 older mCNV patients increased from 0.83 ± 0.30 at baseline to 0.49 ± 0.24 at one year. Baseline BCVA, external limiting membrane damage, CNV area and CNV location correlated with the visual acuity at the 1-year follow-up. There were 7 (33.3%) recurrent cases during the follow-up and the risk of recurrence in patients with baseline central macular thickness (CMT) ≥ 262.86 μm was 14 times greater than that of patients with CMT < 262.86 μm. The risk of recurrence increased 1.84 times for every 100-μm increment in the CMT. Patients over 50 years with mCNV had a worse BCVA, thinner choroid, and higher risk of VIA than young mCNV patients. The standard Conbercept treatment strategy was safe and effective in mCNV patients over 50 years. As patients over 50 years with a greater CMT have a high risk of recurrence, more attention should be paid on these patients by following them up closely.
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... We therefore strongly believe that interpretation of mCNV features on OCTA is inter-observer dependent and that artifacts and acquisition modality can greatly affect diagnosis, eventually leading to poor quality imaging in almost 24.1% of cases [5]. Nevertheless, we reported that in 80% of fibrosis secondary to mCNV (inactive mCNV), the original neovascular network remains well discernable several months after treatment even if enclosed within the scar area [6]. This observation, in particular, seems inconsistent with the proposed algorithm. ...
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... Using the above-described (see Methods) grading system, not only patients with complete ELM integrity but also those with less severe disruptions were included in the group of "better ELM integrity" and showed better visual outcomes than those with severe disruptions. In a retrospective analysis with variable follow-up time, Milani et al. [32] reported that any ELM disruption was present in 68% of eyes at baseline, which was reduced to 41% during follow-up. Complete integrity of lesion-adjacent ELM and of lesion-adjacent ellipsoid zone at baseline seemed to be factors for better final BCVA. ...
Outcome Predictors of SD-OCT-Driven Intravitreal Ranibizumab in Choroidal Neovascularization due to Myopia
Article
Full-text available
  • Aug 2019
Purpose: To analyze the efficacy and outcome predictors of SD-OCT (spectral-domain optical coherence tomography)-driven ranibizumab treatment in patients with choroidal neovascularization due to myopia (mCNV). Methods: This prospective investigator-initiated study includes 20 patients with treatment-naïve mCNV. Evaluation included best-corrected visual acuity (BCVA), morphological SD-OCT parameters, and treatment frequency. Results: From baseline to month 12, BCVA improved from 58.5 ± 16.9 to 66.1 ± 14.9 letters. Central retinal thickness (CRT) significantly decreased, and qualitative SD-OCT parameters improved. Better baseline visual acuity (VA), lower spherical equivalent, better inner/outer segment line and external limiting membrane integrity showed a significant positive effect on BCVA outcome. Less fluctuation in CRT (worst minus best CRT) indicated better BCVA at 12 months. No serious adverse events occurred. Conclusions: SD-OCT-guided intravitreal ranibizumab treatment in mCNV was efficient and safe. We determined useful predictive factors in regard to VA outcome after 12 months.
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Factors influencing ellipsoid zone tear in pathologic myopia choroidal neovascularization
Preprint
Full-text available
  • May 2022
This study explored factors influencing ellipsoid zone (EZ) tear in pathologic myopia choroidal neovascularization (PM-CNV) and its relationship with visual acuity mainly using optical coherence tomography (OCT). We divided 21 (22 eyes) PM-CNV patients, who were divided into non-tear (n=10) and tear (n=12) groups by whether the EZ was torn or not. Measured central macular thickness (CMT), PM-CNV lesion hyperreflectivity (HF) height and area, and myoid ellipsoid zone (MEZ)) thickness on OCT. Analyzing relationships between these factors and EZ tearing. We found EZ tear group had thicker CMT (P = 0.006), higher HF height (P = 0.001), larger HF area (P = 0.001), bigger PM-CNV area (P = 0.028), greater HF/CNV area ratio (P = 0.038), thinner MEZ (P = 0.000), worse best corrected visual acuity (BCVA) (P = 0.000). After treatment with conbercept only 4/12 eyes showed recovery of EZ integrity in tear group, with even worse BCVA. OCT provides a new bioindicator as monitoring risk factor of EZ tear for PM-CNV. PM-CNV with higher and larger HF, bigger HF area relative to the PM-CNV area have greater risk for EZ tear and poorer visual acuity. Better visual acuity will be achieved when PM-CNV was treated before EZ tear.
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ASSESSING THE ABILITY OF PREOPERATIVE QUANTITATIVE SPECTRAL-DOMAIN OPTICAL COHERENCE TOMOGRAPHY CHARACTERISTICS TO PREDICT VISUAL OUTCOME IN IDIOPATHIC MACULAR HOLE SURGERY
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  • Apr 2020
  • RETINA-J RET VIT DIS
Purpose: To determine which spectral domain optical coherence tomography biomarkers of idiopathic macular hole (MH) correlate with the postoperative best-corrected visual acuity (BCVA) in anatomically closed MH. Methods: Retrospective analysis of spectral domain optical coherence tomography scans of 44 patients presenting with MH followed for a mean of 17 months. Widths of MH aperture, base, and ellipsoid zone disruption were calculated from presenting foveal spectral domain optical coherence tomography B-scans. Macular hole base area and ellipsoid zone disruption area were calculated through the custom in-house software. Results: Poorer postoperative BCVA correlated with increased preoperative choroidal hypertransmission (r = 0.503, P = 0.0005), minimum diameter (r = 0.491, P = 0.0007), and base diameter (r = 0.319, P = 0.0348), but not with preoperative ellipsoid zone width (r = 0.199, P = 0.2001). Applying en-face analysis, the BCVA correlated weakly with preoperative ellipsoid zone loss area (r = 0.380, P = 0.013), but not with preoperative MH base area (r = 0.253, P = 0.1058). Conclusion: Increased MH minimum diameter, base diameter, base area, and choroidal hypertransmission are correlated with a poorer postoperative BCVA. Ellipsoid zone loss measurements were not consistently correlated with a BCVA. Choroidal hypertransmission width may be an easy-to-visualize predictive imaging biomarker in MH surgery.
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Risk factors for subretinal fibrosis after anti-VEGF treatment of myopic choroidal neovascularisation
Article
  • Mar 2020
Purpose To assess the incidence, clinical features and predictive risk factors of subretinal fibrosis after treatment of active myopic choroidal neovascularisation (mCNV) with anti-vascular endothelial growth factor (VEGF). Methods This post-hoc analysis of a randomised controlled trial included a total of 54 patients with active mCNV. The clinical data at baseline, month 3 and month 12 were used. Fundus photography and optical coherence tomography at month 3 were used to determine the presence of subretinal fibrosis after anti-VEGF therapy, and its incidence was calculated. Best-corrected visual acuity (BCVA), Visual Function Questionnaire−25 score, macular integrity index (MI) and their changes were compared between eyes with and without subretinal fibrosis. A logistic regression model was used to evaluate the risk factors of subretinal fibrosis. Results Subretinal fibrosis occurred in 22 of 54 eyes with mCNV. Patients with subretinal fibrosis achieved similar BCVA improvement in comparison with those without fibrosis at 3 and 12 months after the treatment; however, they had lower visual acuity, more subfoveal CNV (p=0.002), higher CNV thickness at baseline (p=0.016), larger CNV size (p=0.030), larger leakage area (p=0.021) and higher presence of advanced myopic maculopathy (p=0.035). Age <45 years, BCVA <60 ETDRS letters, and MI index <20 at baseline were the predictors for subretinal fibrosis occurrence in a logistic regression model. Conclusions The incidence of subretinal fibrosis after anti-VEGF therapy was 40.7% in eyes with mCNV. Age, baseline BCVA and MI index could serve as predictive risk factors of subretinal fibrosis after anti-VEGF treatment in patients with mCNV.
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Correlation Between Hyperreflective Foci and Clinical Outcomes in Neovascular Age-Related Macular Degeneration After Switching to Aflibercept
Article
Full-text available
  • Oct 2015
Purpose: To assess the correlation between hyperreflective foci (HF) and visual and anatomical outcomes in treatment-resistant neovascular age-related macular degeneration (AMD) using spectral-domain optical coherence tomography (SD-OCT). Methods: This was a prospective interventional case series. Thirty-three eyes of 30 consecutive patients with treatment-resistant neovascular AMD were enrolled. Intravitreal aflibercept injections were performed at week 0 (baseline), week 4, and week 8. Spectral-domain OCT images were obtained before each injection and 4 weeks after the third injection. The main focus was on the measurement of choroidal neovascularization (CNV) size in the cross-sectional area in the B-scan through the fovea, and HF number along line segments of 1- and 3-mm length passing through the fovea. Results: Mean number of HF in the radius of 500 μm decreased from 8.36 ± 7.58 to 4.15 ± 3.39 (P = 0.02). Mean number of HF in the radius of 1500 μm was reduced from 21.30 ± 12.47 to 10.45 ± 6.34 (P < 0.001). Mean CNV area decreased from 0.35 ± 0.22 to 0.22 ± 0.16 mm2 (P < 0.001). There was a significant positive correlation between HF reduction in the radius of 500 μm and decrease in central subfield thickness (CST) (r = 0.43, P = 0.01), but no statistically significant correlation was found between HF decline in the radius of 1500 μm and other parameters. Conclusions: Switching from ranibizumab to aflibercept caused significant decrease in the number of HF 1 month after aflibercept upload, and HF decrease in the radius of 500 μm was correlated positively with the reduction in CST.
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Submacular hemorrhage in neovascular age-related macular degeneration: A synthesis of the literature
Article
  • Jul 2015
Large submacular hemorrhage is an uncommon manifestation of neovascular age-related macular degeneration. It can also occur with idiopathic polypoidal choroidal vasculopathy. Submacular hemorrhage damages photoreceptors owing to iron toxicity, fibrin meshwork contraction, and reduced nutrient flux, with subsequent macular scarring. Clinical and experimental studies support prompt treatment, as tissue damage can occur within 24 hours. Without treatment the natural history is poor, with a mean final visual acuity (VA) of 20/1600. Reported treatments include retinal pigment epithelial patch, macular translocation, pneumatic displacement, intravitreal or subretinal tissue plasminogen activator (TPA), intravitreal anti-vascular endothelial growth factor (VEGF) drugs, and combinations thereof. In the absence of comparative studies, we combined eligible studies to assess the VA change before and after each treatment option. The greatest improvement occurred following combined pars plana vitrectomy, subretinal TPA, intravitreal gas, and anti-VEGF treatment, with VA improving from 20/1000 to 20/400. The best final VA occurred using combined intravitreal TPA, gas and anti-VEGF therapy, with VA improving from 20/200 to 20/100. Both treatments had an acceptable safety profile, but most studies were small, and larger randomized controlled trials are needed to determine both safety and efficacy. Copyright © 2015 Elsevier Inc. All rights reserved.
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Correspondence of leakage on fluorescein angiography and optical coherence tomography parameters in diagnosis and monitoring of myopic choroidal neovascularization treated with bevacizumab
Article
  • Jul 2015
To describe the morphologic alterations on spectral domain optical coherence tomography in active myopic choroidal neovascularization (CNV) receiving intravitreal bevacizumab and to evaluate its diagnostic accuracy, taking fluorescein angiography as a reference examination. Thirty patients (30 eyes) were prospectively enrolled. Each eye was imaged with fluorescein angiography and spectral domain optical coherence tomography at the baseline and at 1-, 2-, and 3-month examinations. Spectral domain optical coherence tomography parameters consisting of intraretinal/subretinal fluid and absence of external limiting membrane (ELM) visibility were considered signs of CNV activity and collated with the presence/absence of leakage on fluorescein angiography. Main outcome measures were frequencies of the retinal alterations associated with myopic CNV at the diagnosis and during monitoring of anti-vascular endothelial growth factor therapy. At the diagnosis, spectral domain optical coherence tomography identified subretinal fluid in 14 eyes (46%), intraretinal fluid associated with subretinal fluid in 12 eyes (40%), and absence of ELM visibility in 30 of the 30 eyes (100%). During the follow-up, fluorescein leakage was noted in 32 visits (18, 8, and 6 eyes at the 1-, 2- and 3-month examinations, respectively). Taking into consideration spectral domain optical coherence tomography features of active myopic CNVs on fluorescein angiography, subretinal fluid was identified in 24 examinations (75%), intraretinal cysts with subretinal fluid were noted in 5 visits (15.6%), and the absence of ELM visibility was visible in 32 examinations (100%). The alterations of the ELM corresponded to the location of the fluorescein leakage. This study provides evidence that the absence of ELM visibility is a more reliable parameter for evaluating CNV activity than intraretinal/subretinal fluid collection and may constitute a useful option in diagnosing and monitoring the myopic CNV during anti-vascular endothelial growth factor therapy.
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Spectral-Domain Optical Coherence Tomography of Subretinal Hyperreflective Exudation in Myopic Choroidal Neovascularization
Article
  • Jul 2015
To study the effect of anti-Vascular Endothelial Growth Factor (VEGF) therapy on subretinal hyper reflective exudation detected by spectral-domain optical coherence tomography (SD-OCT) in myopic choroidal neovascularization (CNV). Retrospective consecutive observational cohort study. 31 eyes of 31 consecutive highly myopic patients with CNV and showing a subretinal hyper reflective exudation on SD-OCT were included. Morphological changes were assessed before and after anti-VEGF therapy, based on the subretinal hyper reflective exudation thickness, retinal thickness at the level of the CNV and central macular thickness. After anti-VEGF treatment (mean follow-up of 1.9 ± 0.8 months, mean number of injections 1.8 ± 0.6), the subretinal hyper reflective exudation regressed completely in 29/31 eyes (93.5%) and partially in 2/31 eyes (6.5%). Mean subretinal hyper reflective exudation thickness, mean retinal thickness at the level of the CNV and mean central macular thickness significantly decreased from 102 ± 50 μm to 2.6 ± 10.2 μm (P < 0.0001), 419 ± 99 μm to 312 ± 64 μm (P < 0.0001) and 361 ± 69 μm to 326 ± 72 μm (P = 0.0008), respectively. The subretinal hyper reflective exudation was a SD-OCT finding that correlated with signs of active myopic CNV (either subretinal fluid/intraretinal cysts on SD-OCT or dye leakage on fluorescein angiography) and responded to treatment with anti-VEGF agents. The presence of a subretinal hyper reflective exudation on SD-OCT could help making decisions on the need to perform or not fluorescein angiography, and regarding treatment or retreatment. Copyright © 2015 Elsevier Inc. All rights reserved.
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Intravitreal Aflibercept Injection in Patients with Myopic Choroidal Neovascularization: The MYRROR Study
Article
  • Mar 2015
To evaluate intravitreal aflibercept 2 mg in patients with myopic choroidal neovascularization (CNV). An international, phase III, multicenter, randomized, double-masked, sham-controlled study. Patients aged ≥18 years with high myopia (≤-6.0 diopters or axial length of ≥26.5 mm), active myopic CNV, and best-corrected visual acuity (BCVA) of 73-35 Early Treatment Diabetic Retinopathy Study letters in the study eye were included. Patients were randomized 3:1 to intravitreal aflibercept or sham. In the intravitreal aflibercept arm, patients received 1 injection at baseline. Additional injections were performed in case of CNV persistence or recurrence at monthly visits through week 44. In the sham arm, patients received sham injections through week 20. At week 24, after assessment of the primary efficacy end point, sham patients received a mandatory intravitreal aflibercept injection followed by intravitreal aflibercept (if disease persisted/recurred) or sham injection every 4 weeks. Mean change in BCVA from baseline to week 24. A total of 122 patients were randomized to intravitreal aflibercept (n = 91) or sham (n = 31). Baseline demographics were similar across groups. At week 24, patients in the intravitreal aflibercept and sham groups gained 12.1 and lost 2 letters, respectively (P < 0.0001). By week 48, patients in the intravitreal aflibercept and sham/intravitreal aflibercept groups gained 13.5 and 3.9 letters. Patients in the intravitreal aflibercept group received 2 injections (median) in the first study quarter (week 0-8). Median number of injections in quarters 2 to 4 was 0. Patients in the "sham/intravitreal aflibercept" group received 2 and 1 (median) intravitreal aflibercept injections in quarters 3 and 4. Central retinal thickness improved in parallel with visual gains. Incidence of ocular adverse events was similar in both groups through week 48 (37.4% vs. 38.7); most were assessed by investigators as mild. No deaths occurred. Intravitreal aflibercept 2 mg was effective for treatment of myopic CNV with clinically important visual and anatomic benefits achieved with a limited number of injections given in the first 8 weeks of treatment. No new safety concerns occurred with treatment. Intravitreal aflibercept should be considered as a treatment option for myopic CNV. Copyright © 2015 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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Optical coherence tomographic hyperreflective foci in early stages of diabetic retinopathy
Article
  • Aug 2014
Purpose: To analyze the presence of hyperreflective foci in Type 1 and Type 2 diabetic patients, separately, without clinically significant diabetic macular edema and visual impairment. Methods: Noninvasive, observational prospective study. Seventeen and 19 consecutive Type 1 and Type 2 diabetic patients (33 and 38 eyes), respectively, were recruited. All patients had no clinically significant diabetic macular edema or visual impairment. Two age- and sex-matched control groups were also included. Patients underwent an ophthalmologic examination including spectral domain optical coherence tomography. Hyperreflective foci were counted considering horizontal B-scan passing through the fovea. Results: On spectral domain optical coherence tomography, patients affected by Type 1 and Type 2 diabetes had a mean of 7.5 ± 4.6 and 9.9 ± 4.5 hyperreflective foci, respectively. Subjects of control groups had a mean of 0.9 ± 0.8 and 1.7 ± 1.5 hyperreflective foci, respectively. Hyperreflective foci amount was statistically different between Type 1 and Type 2 diabetic groups (P = 0.032) and significantly higher in diabetic patients than in controls (P < 0.001). Hyperreflective foci amount was significantly higher in diabetic patients with a poor quality glycometabolic control (P < 0.001 and P = 0.016) or affected by hypertension (P = 0.008). Conclusion: We reported the presence of hyperreflective foci in diabetic patients without diabetic macular edema and visual impairment. This spectral domain optical coherence tomography finding might be a useful marker for the diagnosis and the follow-up in the early stage of diabetic retinopathy.
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Anti-VEGF Therapy in Myopic Choroidal Neovascularization: Long-Term Results
Article
  • May 2014
  • OPHTHALMOLOGICA
Purpose: To evaluate the medium- and long-term efficacy of anti-VEGF agents in the treatment of choroidal neovascularization secondary to pathologic myopia (mCNV). Methods: We performed a retrospective analysis of patients with mCNV who had been treated with intravitreous anti-VEGF for at least 2 years. The best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were compared before and after the treatment. The number of injections per year was also assessed. Results: The results were analysed at 2 years for 67 eyes, at 3 years for 52 eyes, at 4 years for 28 eyes and at 5 years for 13 eyes. The mean change from baseline BCVA was significant at 2 years (+8.6 letters; p < 0.001) and this gain remained significantly stable for a period of 5 years. The mean CRT showed a significant decrease over time, with a nadir at 2 years (-104.0 μm; p < 0.001). The mean number of injections performed during the first year was 5.2, being lower in subsequent years (p < 0.001). Conclusion: In this subset of patients with mCNV, an intravitreous therapy with anti-VEGF agents proved to have effective results over 5 years, with a sustained increase in BCVA. © 2014 S. Karger AG, Basel.
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Imaging of Naive Myopic Choroidal Neovascularization by Spectral-Domain Optical Coherence Tomography
Article
  • Apr 2014
  • OPHTHALMOLOGICA
Purpose: To assess the tomographic features of myopic choroidal neovascularization by spectral-domain optical coherence tomography. Methods: We consecutively reviewed the charts of patients with pathologic myopia, recent visual acuity deterioration and active macular neovascularization. Specific tomographic changes were studied in 25 eyes by two authors independently. Results: The mean age of patients eligible for the study was 63.4 (±18.2) years. Main tomographic outcomes were the hyperreflectivity of the lesion in 88% of cases (95% CI 0.74-1.02), absence of the external limiting membrane in 88% (95% CI 0.84-1.02), and retinal thickening in 83% (95% CI 0.67-0.99). The internal plexiform layer remained discernible in 83% (95% CI 0.67-0.99) of cases, the inner nuclear layer in 62% (95% CI 0.37-0.80), the external plexiform layer in 48% (95% CI 0.27-0.69). Retinal edema was noted in 48% (95% CI 0.26-0.70) of patients. Conclusions: Myopic choroidal neovascularization appears predominantly hyperreflective, causes thickening of the corresponding retina and mainly involves the external retinal segments. Retinal fluid is infrequent. © 2014 S. Karger AG, Basel.
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Macular Microstructures and Prognostic Factors in Myopic Subretinal Hemorrhages
Article
  • Dec 2013
Purpose: To investigate microstructural changes and visual prognosis in myopic subretinal hemorrhages (mSH) without choroidal neovascularization (CNV). Methods: In this retrospective, observational case series, 13 consecutive eyes with mSH were followed for 6 months. The medical records, fluorescein angiography (FA), and spectral-domain optical coherence tomography (OCT) were reviewed. Fluorescein angiography confirmed the absence of CNV. The baseline and 6-month findings/parameters were investigated, including the maximal hemorrhagic height, intraretinal hyperscattering signal across the retina at 6 months (i.e., intraretinal hyperreflective sign), and integrity of the photoreceptor inner and outer segment (IS/OS) and external limiting membrane (ELM) lines. Results: The final visual acuity (VA) improved significantly (P = 0.001), and the hemorrhages resolved in 12 (92.3%) eyes by 6 months. The tops of the hemorrhages reached the outer nuclear layer (ONL) in three eyes (23.1%), internal limiting membrane (ILM) in five (38.5%), and between the two layers in five (38.5%). The intraretinal hyperreflective sign in all eyes extended into the ONL in five eyes (38.5%), to the ILM in four (30.8%), and between the two layers in four (30.8%). The location of the hyperreflective signs at 6 months coincided with the ruptured retinal layers at baseline in all eyes. The IS/OS line and the ELM were each intact in six (46.2%) eyes. The final VA was associated significantly with the IS/OS (P < 0.05) and ELM (P < 0.01) integrity. Conclusions: The intraretinal hyperreflective sign, presumed to be scarring that enters through the disrupted outer retina, is correlated closely with photoreceptor function.
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Epidemiology and Disease Burden of Pathologic Myopia and Myopic Choroidal Neovascularization: An Evidence-Based Systematic Review
Article
  • Oct 2013
To summarize the epidemiology of pathologic myopia and myopic choroidal neovascularization (CNV) and their impact on vision. Systematic literature review of all English-language studies evaluating the epidemiology and visual burden of pathologic myopia or myopic CNV. PubMed and EMBASE were searched with no time limits using predefined search strings for English-language studies evaluating the epidemiology and visual burden of pathologic myopia and myopic CNV. In total, 39 relevant publications were identified. Population-based studies reported pathologic myopia to be the first to third most frequent cause of blindness. The prevalence of pathologic myopia was reported to be 0.9%-3.1%, and the prevalence of visual impairment attributable to pathologic myopia ranged from 0.1%-0.5% (European studies) and from 0.2%-1.4% (Asian studies). The prevalence of CNV in individuals with pathologic myopia was reported to be 5.2%-11.3%, and was bilateral in approximately 15% of patients. All studies of visual outcome in patients with myopic CNV (duration ranging from less than 3 months to 21.5 years) reported deterioration in best-corrected visual acuity over time. Older age, subfoveal CNV location, and larger baseline lesion size were predictors of worse visual outcomes. Pathologic myopia is an important cause of vision loss worldwide, affecting up to 3% of the population. Of these, a substantial proportion of patients develop myopic CNV, which mostly causes a significant progressive decrease in visual acuity. This condition should therefore be a target for new treatment strategies.
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