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ABSTRACT: OBJECTIVE To compare baseline characteristics and treatment response of participants with hemiretinal vein occlusion (HRVO) with those of participants with branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO) in the Standard Care vs COrticosteroid for REtinal Vein Occlusion (SCORE) Study. METHODS Eyes were randomized to standard care, 1 mg intravitreal triamcinolone acetonide, or 4 mg intravitreal triamcinolone acetonide. Standard care was observation in the SCORE-CRVO trial and grid photocoagulation in the SCORE-BRVO trial. The HRVO eyes were enrolled in the SCORE-BRVO trial. Baseline characteristics, changes in visual acuity and center point thickness, safety outcomes, and number of treatments were compared among HRVO, BRVO, and CRVO participants. RESULTS At baseline, HRVO eyes were intermediate between BRVO and CRVO eyes in area of retinal thickening, area of fluorescein leakage, visual acuity, and center point thickness. No differences in visual acuity change from baseline to 1 year were noted between standard care groups for HRVO and BRVO. Within triamcinolone-treated eyes, HRVO eyes did not differ from BRVO eyes in visual acuity change, but HRVO eyes fared better than CRVO eyes. There were no differences in center point thickness change between standard care groups for HRVO and BRVO, nor were there differences across the 3 disease entities for triamcinolone-treated eyes. There were no differences in frequency of protocol treatments and adverse events. CONCLUSIONS The HRVO participants were similar to BRVO and CRVO participants regarding most demographic characteristics, with fundus findings intermediate between BRVO and CRVO. In the SCORE Study, HRVO was treated as BRVO; HRVO eyes responded to treatment similarly to BRVO eyes, and there was no difference among the 3 disease entities in frequency of protocol treatments and adverse events. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT00105027.
Archives of ophthalmology 12/2012; 130(12):1517-1524. · 3.86 Impact Factor
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ABSTRACT: PURPOSE:: To investigate the prevalence of venous collaterals after branch and central retinal vein occlusion, assess the association of venous collaterals with other clinical features (including visual acuity), and determine if treatment with intravitreal corticosteroids influences the development of new venous collaterals. METHODS:: Review of data from two multicenter randomized clinical trials in the Standard of Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study. RESULTS:: Statistically significant associations of venous collaterals and visual acuity at baseline or at follow-up were not found. Treatment with intravitreal triamcinolone acetonide did not appear to influence the development of venous collaterals. CONCLUSION:: In contrast to some previous reports, development of venous collaterals did not demonstrate an independent association with visual acuity in eyes with branch retinal vein occlusion or central retinal vein occlusion in the SCORE Study. Intravitreal steroid effects do not appear to influence the development of venous collaterals.
Retina (Philadelphia, Pa.) 09/2012; · 2.93 Impact Factor
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ABSTRACT: In clinical trials of treatment for stimulant abuse, researchers commonly record both Time-Line Follow-Back (TLFB) self-reports and urine drug screen (UDS) results.
To compare the power of self-report, qualitative (use vs. no use) UDS assessment, and various algorithms to generate self-report-UDS composite measures to detect treatment differences via t-test in simulated clinical trial data.
We performed Monte Carlo simulations patterned in part on real data to model self-report reliability, UDS errors, dropout, informatively missing UDS reports, incomplete adherence to a urine donation schedule, temporal correlation of drug use, number of days in the study period, number of patients per arm, and distribution of drug-use probabilities. Investigated algorithms include maximum likelihood and Bayesian estimates, self-report alone, UDS alone, and several simple modifications of self-report (referred to here as ELCON algorithms) which eliminate perceived contradictions between it and UDS.
Among the algorithms investigated, simple ELCON algorithms gave rise to the most powerful t-tests to detect mean group differences in stimulant drug use.
Further investigation is needed to determine if simple, naïve procedures such as the ELCON algorithms are optimal for comparing clinical study treatment arms. But researchers who currently require an automated algorithm in scenarios similar to those simulated for combining TLFB and UDS to test group differences in stimulant use should consider one of the ELCON algorithms.
This analysis continues a line of inquiry which could determine how best to measure outpatient stimulant use in clinical trials (NIDA. NIDA Monograph-57: Self-Report Methods of Estimating Drug Abuse: Meeting Current Challenges to Validity. NTIS PB 88248083. Bethesda, MD: National Institutes of Health, 1985; NIDA. NIDA Research Monograph 73: Urine Testing for Drugs of Abuse. NTIS PB 89151971. Bethesda, MD: National Institutes of Health, 1987; NIDA. NIDA Research Monograph 167: The Validity of Self-Reported Drug Use: Improving the Accuracy of Survey Estimates. NTIS PB 97175889. GPO 017-024-01607-1. Bethesda, MD: National Institutes of Health, 1997).
The American Journal of Drug and Alcohol Abuse 09/2011; 37(5):350-7. · 1.55 Impact Factor
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ABSTRACT: To investigate in The Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study: (1) incidences of neovascular events and retinal capillary nonperfusion (abbreviated as "nonperfusion"), and their relationship with treatment groups; (2) neovascular incidences by nonperfusion status; and (3) pertinent baseline factors for their potential risk for neovascular events.
Two multicenter, randomized clinical trials, 1 evaluating participants with central retinal vein occlusion (CRVO) and the other evaluating participants with branch retinal vein occlusion (BRVO).
At 36 months, data were available for 81 participants with CRVO and 128 with BRVO.
Standard care (observation or grid photocoagulation) versus 1 or 4 mg intravitreal triamcinolone.
Neovascularization of the iris (NVI), neovascular glaucoma (NVG), disc or retinal neovascularization (NVD/NVE), preretinal or vitreous hemorrhage (PRH/VH), and nonperfusion.
The cumulative 36-month incidences for CRVO and BRVO eyes, respectively, were 8.5% and 2.4% for NVI or NVG; 8.8% and 7.6% for NVD/NVE or PRH/VH. There were no differences in incidences of neovascular events or risk of nonperfusion when comparing the 3 treatment groups within diseases. For CRVO at 36 months, 16.6% of eyes with ≥5.5 disc areas of nonperfusion versus 4.0% of eyes with <5.5 disc areas of nonperfusion developed NVG (P = 0.0003); for BRVO at 36 months, 14.6% versus 2.4% developed NVD/NVE (P<0.0001). Similar results were noted for most other neovascular events. Nonperfusion was the only significant baseline factor for neovascularization in BRVO, with the risk of a neovascular event increasing with greater disc areas of nonperfusion, and the highest risk noted at ≥5.5 disc areas.
In the SCORE Study, triamcinolone treatment was not associated with lower incidences of neovascular events or nonperfusion status compared with observation or grid photocoagulation. Cumulative 36-month incidences for most neovascular events were significantly higher for nonperfused than perfused eyes. Greater baseline disc areas of nonperfusion increased the risk of neovascularization in BRVO but not CRVO eyes, possibly owing to obscuration of retinal capillary details caused by dense hemorrhage at baseline for CRVO eyes. Increased risk of neovascularization was noted below the historical threshold of 10 disc areas of nonperfusion for retinal vein occlusion.
Ophthalmology 03/2011; 118(7):1364-72. · 5.45 Impact Factor
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ABSTRACT: To investigate baseline factors associated with visual acuity and central retinal thickness outcomes in patients with macular edema secondary to retinal vein occlusion in the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study.
Two multicenter, randomized clinical trials: one evaluating participants with central retinal vein occlusion (CRVO) and one evaluating participants with branch retinal vein occlusion (BRVO).
Participants with follow-up data of 1 year or more, including 238 with CRVO and 367 with BRVO.
Visual acuity was measured by the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) method, and central retinal thickness was measured by optical coherence tomography (OCT). Regression analysis related these outcomes to 20 baseline measures. Multiple P values were adjusted to control the false discovery rate.
Outcome measures of visual acuity letter score included absolute change from baseline, a gain of ≥ 15 from baseline, and a loss of ≥ 15 from baseline. Outcome measures of center point thickness included absolute change from baseline, a measurement of ≤ 250 μm, and a measurement of ≥ 500 μm. Outcomes were assessed at 1 and 2 years.
For CRVO and BRVO, younger age was associated with improved visual acuity and central retinal thickness outcomes. For CRVO, triamcinolone treatment and less severe anatomic abnormalities of the retina (center point thickness and areas of retinal hemorrhage, thickening, and fluorescein leakage) were predictive of better visual acuity outcomes. For BRVO, no history of coronary artery disease was predictive of improved visual acuity outcomes. For center point thickness outcomes, shorter duration of macular edema was associated with improvement in both disease entities. For CRVO, higher baseline visual acuity letter score was predictive of favorable OCT outcomes. For BRVO, lower baseline visual acuity letter score, presence of dense macular hemorrhage, and no prior grid photocoagulation were predictive of favorable OCT outcomes.
Several factors were predictive of better visual acuity outcomes and more favorable OCT outcomes, including younger age and shorter duration of macular edema, respectively. These factors may assist clinicians in predicting disease course for patients with CRVO and BRVO.
Ophthalmology 10/2010; 118(2):345-52. · 5.45 Impact Factor
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ABSTRACT: We compare five closed tests for strong control of family-wide type I error (FWE) while making all pair-wise comparisons of means in clinical trials with multiple arms such as the SCORE Study. We simulated outcomes of the SCORE Study under its design hypotheses, and used p-values from chi-squared tests to compare performance of a "pairwise" closed test described below to Bonferroni and Hochberg adjusted p-values. "Pairwise" closed testing was more powerful than Hochberg's method by several definitions of multiple-test power. Simulations over a wider parameter space, and considering other closed methods, confirmed this superiority for p-values based on normal, logistic, and Poisson distributions. The power benefit of "pair-wise" closed testing begins to disappear with 5 or more arms, and with unbalanced designs. For trials with 4 or fewer arms and balanced designs, investigators should consider using "pair-wise" closed testing in preference to Shaffer's, Hommel's, and Hochberg's approaches when making all pairwise comparisons of means. If not all p-values from the closed family are available, Shaffer's method is a good choice.
Drug information journal 07/2010; 44(4):405-420. · 0.36 Impact Factor
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ABSTRACT: To describe grading procedures for optical coherence tomographic (OCT) images of participants in the Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study.
Optical coherence tomograms were taken at clinical sites with the Stratus OCT using fast macular and crosshair scan protocols. Paper prints of images were evaluated at a central reading center. Quality evaluation identified the accuracy of OCT-measured retinal thickness data and was categorized as good, fair, borderline, or ungradable. Manual measurement of center point thickness was performed on borderline images. Morphological evaluation identified cystoid spaces, subretinal fluid, and vitreoretinal interface abnormalities. Reproducibility of grading was assessed through formal quality control exercises.
A randomly selected set of 106 images was identified for quality control. The first 2 annual regrades showed 91% and 89% intergrader agreement for OCT quality. Intraclass correlation for manually measured center point thickness was 0.99 per year. For morphological variables, intergrader agreement for cystoid spaces was 83% and 76%. Reproducibility for subretinal fluid and vitreoretinal interface abnormalities could not be interpreted owing to their limited presence in the sample.
Optical coherence tomogram evaluation procedures used in the SCORE Study are reproducible and can be used for multicenter longitudinal studies of retinal vein occlusion.
Archives of ophthalmology 11/2009; 127(11):1461-7. · 3.86 Impact Factor
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ABSTRACT: To evaluate the incidence of intravitreal silicone oil (SO) droplets associated with intravitreal injections using a staked-on vs luer cone syringe design in the SCORE (Standard Care vs COrticosteroid in REtinal Vein Occlusion) Study.
Prospective, randomized, phase III clinical trial.
The incidence of intravitreal SO was compared among participants exposed to the staked-on syringe design, the luer cone syringe design, or both of the syringe designs in the SCORE Study, which evaluated intravitreal triamcinolone acetonide injection(s) for vision loss secondary to macular edema associated with central or branch retinal vein occlusion. Injections were given at baseline and 4-month intervals, based on treatment assignment and study-defined retreatment criteria. Because intravitreal SO was observed following injections in some participants, investigators were instructed, on September 22, 2006, to look for intravitreal SO at all study visits. On November 1, 2007, the luer cone syringe design replaced the staked-on syringe design.
A total of 464 participants received a total of 1,205 injections between November 4, 2004 and February 28, 2009. Intravitreal SO was noted in 141 of 319 participants (44%) exposed only to staked-on syringes, 11 of 87 (13%) exposed to both syringe designs, and 0 of 58 exposed only to luer cone syringes (P < .0001). Among participants with first injections after September 22, 2006, intravitreal SO was noted in 65 of 114 (57%) injected only with staked-on syringes compared with 0 of 58 injected only with luer cone syringes. Differential follow-up is unlikely to explain these results.
In the SCORE Study, luer cone syringe design is associated with a lower frequency of intravitreal SO droplet occurrence compared with the staked-on syringe design, likely attributable to increased residual space in the needle hub with the luer cone design.
American journal of ophthalmology 09/2009; 148(5):725-732.e7. · 3.83 Impact Factor
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ABSTRACT: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with observation for eyes with vision loss associated with macular edema secondary to perfused central retinal vein occlusion (CRVO).
Multicenter, randomized, clinical trial of 271 participants.
Gain in visual acuity letter score of 15 or more from baseline to month 12.
Seven percent, 27%, and 26% of participants achieved the primary outcome in the observation, 1-mg, and 4-mg groups, respectively. The odds of achieving the primary outcome were 5.0 times greater in the 1-mg group than the observation group (odds ratio [OR], 5.0; 95% confidence interval [CI], 1.8-14.1; P = .001) and 5.0 times greater in 4-mg group than the observation group (OR, 5.0; 95% CI, 1.8-14.4; P = .001); there was no difference identified between the 1-mg and 4-mg groups (OR, 1.0; 95% CI, 0.5-2.1; P = .97). The rates of elevated intraocular pressure and cataract were similar for the observation and 1-mg groups, but higher in the 4-mg group.
Intravitreal triamcinolone is superior to observation for treating vision loss associated with macular edema secondary to CRVO in patients who have characteristics similar to those in the SCORE-CRVO trial. The 1-mg dose has a safety profile superior to that of the 4-mg dose. Application to Clinical Practice Intravitreal triamcinolone in a 1-mg dose, following the retreatment criteria applied in the SCORE Study, should be considered for up to 1 year, and possibly 2 years, for patients with characteristics similar to those in the SCORE-CRVO trial. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
Archives of ophthalmology 09/2009; 127(9):1101-14. · 3.86 Impact Factor
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ABSTRACT: To compare the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone with standard care (grid photocoagulation in eyes without dense macular hemorrhage and deferral of photocoagulation until hemorrhage clears in eyes with dense macular hemorrhage) for eyes with vision loss associated with macular edema secondary to branch retinal vein occlusion (BRVO).
Multicenter, randomized clinical trial of 411 participants. Main Outcome Measure Gain in visual acuity letter score of 15 or more from baseline to month 12.
Twenty-nine percent, 26%, and 27% of participants achieved the primary outcome in the standard care, 1-mg, and 4-mg groups, respectively. None of the pairwise comparisons between the 3 groups was statistically significant at month 12. The rates of elevated intraocular pressure and cataract were similar for the standard care and 1-mg groups, but higher in the 4-mg group.
There was no difference identified in visual acuity at 12 months for the standard care group compared with the triamcinolone groups; however, rates of adverse events (particularly elevated intraocular pressure and cataract) were highest in the 4-mg group. Application to Clinical Practice Grid photocoagulation as applied in the SCORE Study remains the standard care for patients with vision loss associated with macular edema secondary to BRVO who have characteristics similar to participants in the SCORE-BRVO trial. Grid photocoagulation should remain the benchmark against which other treatments are compared in clinical trials for eyes with vision loss associated with macular edema secondary to BRVO. Trial Registration clinicaltrials.gov Identifier: NCT00105027.
Archives of ophthalmology 09/2009; 127(9):1115-28. · 3.86 Impact Factor
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ABSTRACT: To describe the baseline characteristics of the participants in the Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study and to compare with cohorts from other retinal vein occlusion trials. The design of the SCORE Study is also described.
Two, multicenter, Phase III, randomized clinical trials, one involving participants with central retinal vein occlusion (CRVO) and one involving participants with branch retinal vein occlusion (BRVO).
A total of 682 participants, including 271 with CRVO and 411 with BRVO.
Demographic and study eye characteristics are summarized and compared between the CRVO and BRVO study participants.
Baseline ophthalmic characteristics, including visual acuity and duration of macular edema before enrollment, and medical history characteristics, including diabetes mellitus and hypertension.
In the CRVO trial, at baseline, mean visual acuity letter score was 51 ( approximately 20/100), mean optical coherence tomography (OCT)-measured central subfield thickness was 595 microns, mean area of retinal thickening in the macular grid on color photography was 12.3 disc areas (DA), and mean area of fluorescein leakage was 11.0 DA. In the BRVO trial, at baseline, mean visual acuity letter score was 57 ( approximately 20/80), mean OCT-measured central subfield thickness was 491 microns, mean area of retinal thickening in the macular grid on color photography was 7.5 DA, and the mean area of fluorescein leakage was 6.1 DA.
Differences observed in baseline visual acuity, OCT-measured retinal thickness, area of retinal thickening on color photography, and area of fluorescein leakage support the evaluation of CRVO and BRVO in separate trials.
The authors have no proprietary or commercial interest in any of the materials discussed in this article.
Ophthalmology 08/2009; 116(9):1770-1777.e1. · 5.45 Impact Factor
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ABSTRACT: To evaluate interobserver agreement between investigator and Reading Center classification of retinal vein occlusion.
The Standard Care versus COrticosteroid in REtinal Vein Occlusion (SCORE) Study includes 2 multicenter phase 3 randomized clinical trials evaluating the efficacy and safety of intravitreal triamcinolone: one involves participants with central retinal vein occlusion (CRVO) and one for participants with branch retinal vein occlusion (BRVO). Eyes with hemiretinal vein occlusion (HRVO) were classified as BRVO.
A total of 682 SCORE Study participants, including 271 with CRVO and 411 with BRVO.
Participants were enrolled in each trial on the basis of investigator classification of retinal vein occlusion. Definitions of CRVO, BRVO, and HRVO based on clinical findings were specified in the study protocol. At baseline, 7-field color stereoscopic fundus photographs of the study eye of each participant were forwarded to the University of Wisconsin Fundus Photograph Reading Center (Reading Center) for evaluation.
Percent agreement and kappa statistics comparing investigator and Reading Center classification of retinal vein occlusion type.
With HRVO categorized as BRVO (consistent with the SCORE Study design), there was 98.0% agreement between investigator and Reading Center classification (641/654 eyes; kappa = 0.96; 95% confidence interval, 0.94-0.98). Disagreements were fairly evenly divided between classification of an eye as CRVO by the investigator and as BRVO by the Reading Center (7/13 disagreements) and vice versa (6 disagreements). When all 3 disease categories (CRVO, BRVO, and HRVO) were compared, there was 92.2% agreement (603/654; unweighted kappa = 0.86; 95% confidence interval, 0.83-0.90). Most disagreements (38/51, or 74.5%) were between BRVO and HRVO, with 9 between CRVO and BRVO, and 4 between HRVO and CRVO. In univariate analyses, baseline factors significantly associated with disagreement include larger area of capillary loss and black race; black race was the only significant factor in a multivariate analysis.
Investigator and Reading Center agreement was excellent in the SCORE Study; disease classification would have been altered in only 13 eyes (2.0%) had Reading Center eligibility been required. Interobserver agreement was least for classification between BRVO and HRVO.
Ophthalmology 05/2009; 116(4):756-61. · 5.45 Impact Factor
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ABSTRACT: To investigate the relationship between baseline center point retinal thickness measured by optical coherence tomography (OCT) and best-corrected visual acuity in eyes with macular edema associated with retinal vein occlusion and to investigate other factors associated with baseline visual acuity letter score.
The Standard Care versus COrticosteroid for REtinal Vein Occlusion (SCORE) Study includes 2 multicenter, randomized clinical trials: one evaluating participants with central retinal vein occlusion (CRVO) and the other evaluating participants with branch retinal vein occlusion (BRVO).
After omitting 17 participants with missing or unreliable OCT measurements, analyses proceeded with 665 enrolled SCORE Study participants (665 eyes), including 262 with CRVO and 403 with BRVO.
At baseline, center point thickness was measured by OCT (Stratus OCT 3 [n=663] and OCT2 [n=2]; Carl Zeiss Meditech, Dublin, CA), and visual acuity was measured by the electronic Early Treatment Diabetic Retinopathy Study (E-ETDRS) methodology.
Center point thickness and best-corrected E-ETDRS visual acuity letter score.
The correlation coefficient for the association between baseline OCT-measured center point thickness and best-corrected E-ETDRS visual acuity letter score is -0.27 (95% confidence limit: -0.38 to -0.16) for participants in the CRVO trial and -0.28 (95% confidence limit: -0.37 to -0.19) in the BRVO trial. Regression modeling estimated the following decrease in baseline visual acuity letter score for every 100-microm increase in OCT-measured center point thickness: 1.7 letters (P=0.0007) for CRVO and 1.9 letters (P<0.0001) for BRVO. On the basis of multivariate regression models, baseline factors significantly associated (P<0.05, after adjusting for multiple testing) with baseline visual acuity letter score include age and duration of macular edema for CRVO participants and center point thickness and presence of cystoid spaces for BRVO participants.
The correlation between OCT-measured center point thickness and visual acuity letter score is modest. OCT-measured center point thickness represents a useful tool for the detection and monitoring of macular edema in retinal vein occlusion, but it cannot reliably substitute for visual acuity measurements.
Ophthalmology 01/2009; 116(3):504-12. · 5.45 Impact Factor
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Jonghyeon Kim,
Leonard G Dally,
Fred Ederer,
Douglas E Gaasterland, Paul C VanVeldhuisen,
Beth Blackwell,
E Kenneth Sullivan,
Bruce Prum,
George Shafranov,
Allen Beck,
George L Spaeth
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ABSTRACT: To determine the least worsening of a visual field (VF) and the least number of confirming tests needed to identify progression of glaucomatous VF defects.
Cohort study of participants in a clinical trial.
Seven hundred fifty-two eyes of 565 patients with advanced glaucoma.
Visual field tests were quantified with the Advanced Glaucoma Intervention Study (AGIS) VF defect score and the Humphrey Field Analyzer mean deviation (MD). Follow-up was 8 to 13 years.
Two measures based on the AGIS VF defect score: (1) sustained decrease of VF (SDVF), a worsening from baseline by 2 (alternatively, 3 or 4) or more units and sustained for 2 (alternatively, 3) consecutive 6-month visits and (2) after the occurrence of SDVF, the average percent of eyes with worsening by 2 (alternatively, 3 or 4) or more units from baseline. Two similar measures based on MD.
Based on the original AGIS criteria for SDVF (a worsening of 4 units in the AGIS score sustained during 3 consecutive 6-month visits), 31% of eyes had an SDVF. The percent of eyes with a sustained event increases by approximately 10% when either the minimum number of units of field loss or the minimum number of 6-month visits during which the loss is sustained decreases by 1. During 3 years of follow-up after a sustained event, a worsening of at least 2 units was found in 72% of eyes that had a 2-visit sustained event. The same worsening was found in 84% of eyes that had a 3-visit sustained event. Through the next 10 years after a sustained event, based on worsening of 2, 3, or 4 units at 2 or 3 consecutive tests, the loss reoccurred, on average, in >/=75% of study eyes. Results for MD are similar.
In patients with advanced glaucoma, a single confirmatory test 6 months after a VF worsening indicates with at least 72% probability a persistent defect when the worsening is defined by at least 2 units of AGIS score or by at least 2 decibels of MD. When the number of confirmatory tests is increased from 1 to 2, the percentage of eyes that show a persistent defect increases from 72% to 84%.
Ophthalmology 11/2004; 111(11):2109-16. · 5.45 Impact Factor
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ABSTRACT: To present for black and white patients with medically uncontrolled glaucoma 10-year results of treatment with 1 of 2 randomly assigned surgical intervention sequences.
Randomized clinical trial.
Three hundred thirty-two black patients (451 eyes) and 249 white patients (325 eyes). Eyes had glaucoma that could not be controlled with medications alone.
Eyes were randomly assigned to 1 of 2 sequences: argon laser trabeculoplasty (ALT)-trabeculectomy-trabeculectomy (ATT) or trabeculectomy-ALT-trabeculectomy (TAT). Second and third interventions were offered after failure of the preceding intervention. Minimum required intraocular pressure (IOP) for intervention failure ranged upward from 18 mmHg, the value depending on whether recent optic disc or visual field (VF) deterioration occurred, and on the magnitude of the field defect. Patients were observed every 6 months, with total potential follow-up ranging from 8 years, 4 months to 13 years.
The averages over follow-up of (1) the percentage of eyes having moderate loss of VF and (2) the percentage of eyes having moderate loss of visual acuity (VA).
Race-treatment interactions in VF and VA loss are significant for the 2 main outcome measures; therefore, results of treatment sequence differences are presented by race. In black patients the average percent of eyes with VF loss was less in the ATT sequence than in the TAT sequence, a difference that is not statistically significant at any visit. In white patients, conversely, after 18 months the average percent of eyes with VF loss was less in the TAT sequence, a difference that increases and is statistically significant in years 8 to 10. In both black and white patients, the average percent of eyes with VA loss was less in the ATT sequence; this difference is statistically significant throughout 10 follow-up years in black patients and is statistically significant only for the first year in white patients. In both black and white patients, average IOP reductions were greater in the TAT sequence, though the TAT-ATT difference was substantially greater in white patients. In both black and white patients, first-intervention failure rates were substantially lower for trabeculectomy than for trabeculoplasty. Ten-year cumulative incidence of unilateral VF impairment comparable to legal blindness was modest in eyes of black (ATT 11.9%, TAT 18.5%) and white (ATT 9.9%, TAT 7.3%) patients.
Although IOP was lowered in both sequences in black and white patients with medically uncontrolled glaucoma, long-term visual function outcomes were better for the ATT sequence in black patients and better for the TAT sequence in white patients.
Ophthalmology 05/2004; 111(4):651-64. · 5.45 Impact Factor
