AIMS: To compare the outcomes of Ex-PRESS versus trabeculectomy at 3 years. METHODS:Consenting patients aged 18-85 years with medically uncontrolled open-angle glaucoma scheduled fortrabeculectomy were included in this study. 63 subjects were randomised to undergo Ex-PRESS (32) or trabeculectomy (31). Follow-up data included intraocular pressure (IOP), glaucoma medications, visual acuity (VA), complications and additional interventions. Complete success was defined as IOP between 5 and 18 mm Hg and 20% reduction from baseline without glaucoma medications, while qualified success was with or without glaucoma medications. RESULTS:Complete success at 2 and 3 years was 43% vs 42% (p=0.78) and 35% vs 38% (p=0.92) in Ex-PRESS versus trabeculectomy, respectively. Qualified success at 2 and 3 years was 59% vs 76% (p=0.20) and 52% vs 61% (p=0.43) in Ex-PRESS versus trabeculectomy, respectively. Mean IOP at 2 and 3 years was 12.5±5.1 mm Hg vs 10.3±3.7 mm Hg (p=0.07) and 13.3±4.5 mm Hg vs 11.1±4.4 mm Hg (p=0.10) for Ex-PRESS versus trabeculectomy, respectively. At 3 years, 47.6% of Ex-PRESS and 50% of trabeculectomy patients were on glaucoma medications (p=1.00). No difference in VA was found after 3 years (logarithm of minimum angle of resolution 0.43±0.4 vs 0.72±0.8 for Ex-PRESS vs trabeculectomy, p=0.11). When excluding patients who underwent reoperation VA was better in the Ex-PRESS group at 1, 2 and 3 years. There were no complications after the first year in either group. CONCLUSIONS: We found no difference in success rates, mean IOP or other secondary outcomes between Ex-PRESS and trabeculectomy after 3 years of follow-up. TRIAL REGISTRATION NUMBER: NCT01263561; post results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
RCT Entities:
AIMS: To compare the outcomes of Ex-PRESS versus trabeculectomy at 3 years. METHODS: Consenting patients aged 18-85 years with medically uncontrolled open-angle glaucoma scheduled for trabeculectomy were included in this study. 63 subjects were randomised to undergo Ex-PRESS (32) or trabeculectomy (31). Follow-up data included intraocular pressure (IOP), glaucoma medications, visual acuity (VA), complications and additional interventions. Complete success was defined as IOP between 5 and 18 mm Hg and 20% reduction from baseline without glaucoma medications, while qualified success was with or without glaucoma medications. RESULTS: Complete success at 2 and 3 years was 43% vs 42% (p=0.78) and 35% vs 38% (p=0.92) in Ex-PRESS versus trabeculectomy, respectively. Qualified success at 2 and 3 years was 59% vs 76% (p=0.20) and 52% vs 61% (p=0.43) in Ex-PRESS versus trabeculectomy, respectively. Mean IOP at 2 and 3 years was 12.5±5.1 mm Hg vs 10.3±3.7 mm Hg (p=0.07) and 13.3±4.5 mm Hg vs 11.1±4.4 mm Hg (p=0.10) for Ex-PRESS versus trabeculectomy, respectively. At 3 years, 47.6% of Ex-PRESS and 50% of trabeculectomy patients were on glaucoma medications (p=1.00). No difference in VA was found after 3 years (logarithm of minimum angle of resolution 0.43±0.4 vs 0.72±0.8 for Ex-PRESS vs trabeculectomy, p=0.11). When excluding patients who underwent reoperation VA was better in the Ex-PRESS group at 1, 2 and 3 years. There were no complications after the first year in either group. CONCLUSIONS: We found no difference in success rates, mean IOP or other secondary outcomes between Ex-PRESS and trabeculectomy after 3 years of follow-up. TRIAL REGISTRATION NUMBER: NCT01263561; post results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/
Entities:
Keywords:
Glaucoma; Intraocular pressure; Treatment Surgery