Abstract
Purpose: :
To compare the rate of visual recovery after Ex-PRESS vs trabeculectomy.
Methods: :
Patients with uncontrolled OAG were randomized to Ex-PRESS or trabeculectomy (NIH, #NCT01263561). BCVA was recorded at baseline, day 1, weeks 1 & 2 and, 1, 3, 6 & 12 months post-op. Snellen acuities were converted to logMAR. Profile analysis was used to compare VA at each follow-up visit to baseline for each group and between groups. The change in number of Snellen lines at 6 months and 1 year post-op from baseline was compared between groups.
Results: :
64 subjects were enrolled (33 Ex-PRESS, 31 trabeculectomy). All subjects completed 3 months follow-up, 58 completed 6 months and 43 completed 1 year. There was no significant difference in VA between groups at baseline or any study visit. Mean logMAR VA was 0.39±0.56 for Ex-PRESS vs 0.49±0.55 for trabeculectomy at baseline (p=0.47) and 0.48±0.64 for Ex-PRESS vs 0.87±0.83 for trabeculectomy at 1 year (p=0.11). Comparing within each group VA was significantly reduced following surgery. In the Ex-PRESS group VA was significantly decreased compared to baseline at day 1 (p<0.001) and weeks 1 (p=0.002) & 2 (p=0.02). By month 1 VA in the Ex-PRESS group was no longer significantly different from baseline (p=0.42) and remained non significant at subsequent visits. In the trabeculectomy group VA remained significantly lower than baseline at each study visit from day 1 (p<0.001) to 1 year (p<0.001). A median loss of 0 and 1 Snellen lines at 6 months (p=0.05), 1 and 1.5 lines at 1 year (p=0.07) was observed for Ex-PRESS and trabeculectomy, respectively. At last follow-up, 7 subjects in the trabeculectomy compared to 2 in the Ex-PRESS group had lost more than 2 Snellen lines. Reasons for VA loss in the trabeculectomy group included central retinal vein occlusion (1), vitreomacular traction (1), cataract (1) and hypotony (3) and in the Ex-PRESS group included hypotony (1). No cause for reduced VA could be determined for 1 subject in each group.
Conclusions: :
Although no differences in final visual outcomes were found between groups, VA recovered faster in patients following Ex-PRESS than trabeculectomy. At 1 month the VA in Ex-PRESS group was no longer significantly decreased from baseline while in the trabeculectomy VA remained significantly worse than baseline up to 1 year.
Clinical Trial: :
http://www.clinicaltrials.gov NCT01263561
Keywords: visual acuity • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials