Abstract
Purpose: :
Prospective randomized study to assess whether implantation of Ex–PRESS under a scleral flap (USF) is more effective compared with Trabecelectomy (Trab.) in patients with primary open angle glaucoma (POAG) who failed medical treatment and are indicated for glaucoma surgery.
Methods: :
80 naive eyes were randomly assigned to either USF Trabecelectomy. Complete eye examination was done prior to the operation, on the 1st and 7th days, and the 1st, 3rd, 6th and 12 postoperative months. Succes rate, IOP and use of IOP lowering medications were compared.
Results: :
Mean patients age was 62.3+–14.5 years (USF), 68.9+–11.5 years (Trab). Mean follow–up period was 47.2+–13.5 and 49.1+–10.8 weeks for USF and Trab. respectively. Mean IOP 1 year post–op was 12.1+–2.5 mmHg (n=35) and 14.1+–4.4 mmHg (n=37) inthe USF and Trabecelectomy (40,5 and 29,1% reduction) respectively. At 1 year post operative the % of patients on medications was 12% and 29% for USF and Trabecelectomy, respectively. The complete success(4mmHg<IOP<21mmHg) without medication) at last visit was 70% and 60% for USF and Trabecelectomy respectively. The qualified success (4mmHg<21mmHg with or without medication) at last visit was 98% and 88% for USF and Trabecelectomy respectively. Thirty five (35) and 37 subjects reached 1 year follow–up for USF and Trabecelectomy respectively.The complete succes at 1 year was 83.3% and 62.2% for USF and Trabecelectomy respectively. The qualified succes at 1 year was 100% and 89% for USF and Trabecelectomy respectively.
Conclusions: :
The Ex–PRESS impant under a scleral flap has a more effective success rate, % IOP reduction and medication reduction compared to Trabecelectomy.
Keywords: clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials • clinical (human) or epidemiologic studies: systems/equipment/techniques • wound healing