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Graham Eric Trope, Johanna Gonzalez, Lilach D Wagschal, Delan Jinapriya, Yvonne M Buys; Trabeculectomy versus Ex-PRESS™: 3 year-follow up. Invest. Ophthalmol. Vis. Sci. 2014;55(13):3171.
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To compare the 3-year outcome of Ex-PRESS vs trabeculectomy.
Charts of patients previously enrolled in a 1-year RCT comparing Ex-PRESS to trabeculectomy were reviewed to obtain 3-year follow-up data. Patients aged 18-85 years diagnosed with glaucoma inadequately controlled on maximal medical therapy and scheduled for trabeculectomy participated in this study. Exclusion criteria included previous ocular surgery (except for phacoemulsification or one previous trabeculectomy), uveitis, vitreous in the anterior chamber and unwilling to provide consent. Information abstracted included IOP, glaucoma medications, visual acuity (VA), complications and additional interventions. Compete success was defined as IOP between 5-18 mmHg and a 20% reduction from baseline and no additional glaucoma procedures. Qualified success was the same ± glaucoma meds. Statistical analysis was carried out using Student t-test and Fishers exact test. This study was registered as a clinical trial with the US NIH.
63 subjects were initially enrolled (32 Ex-PRESS; 31 trabeculectomy). Nine patients died before reaching 3 years (5 Ex-PRESS; 4 trabeculectomy). There was no difference in baseline characteristics between groups. Mean baseline IOP was 22.7±10.3 in the Ex-PRESS vs 22.0±6.8 in the trabeculectomy groups (p=0.76). IOP was significantly reduced from baseline in both groups. Mean IOP at 2 and 3 years was 12.5±5.1 vs 10.5±4.1 (p=0.73) and 13.6±5.0 vs 10.6±4.9 (p=0.73) for Ex-PRESS vs trabeculectomy respectively. Complete success at 2 and 3 years was 50% vs 41% (p=0.59) and 25% vs 41.1% (p=0.48) in the Ex-PRESS vs trabeculectomy groups respectively. Qualified success at 2 and 3 years was 57% vs 79% (p=0.09) and 42% vs 59% (p=0.33) in the Ex-PRESS vs trabeculectomy groups respectively. At 3 years 57.1% of Ex-PRESS and 50.0% of trabeculectomy patients were on glaucoma medications (p=0.1). Mean logMAR VA was better at 2 years in the Ex-PRESS group (0.40 vs 0.77; p<0.05), but not statistically different at 3 years. There were no complications after the first year in either group. 30% of Ex-PRESS vs 17.6% of trabeculectomy (p=0.46) patients underwent additional glaucoma surgery.
At 3 years we found no statistically significant difference in IOP, success, number of glaucoma meds and complications between Ex-PRESS and trabeculectomy. At 2 years VA was significantly better in the Ex-PRESS group however at 3-years there was no difference.
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