One year safety and endothelial cell count results of a prospective and randomized comparison of Ex-Press Vs Deep Sclerectomy combined surgery in glaucoma patients.

Abstract

Purpose : To evaluate safety and endothelial cell count of Ex-PRESS implant vs. Non-Penetrating Deep Sclerectomy (DS) combined with cataract.

Methods : Prospective, multicentre, single-blinded, and randomized trial. Eyes with open angle glaucoma and cataract, requiring combined surgery, were randomly assigned to either filtration surgery with Ex-PRESS (Alcon) or DS with ESNOPER implant (AJL). Main outcomes measures were mean IOP and incidence of complications. Total sample size was 100 subjects (50 in each group) and 2 subjects died during the study due to causes unrelated to surgery. Interventions: Phacoemulsification with Ex-PRESS P50 device or NPDS with scleral implant. A square scleral flap was performed of 4 x 4 mm and 5 x 5 mm in ExPRESS and NPDS groups, respectively. Mitomycin C 0.2 mg/ml for 2 minutes was applied on the sclera in both groups. Adverse events were systematically checked for at every visit and endothelial cell count was performed at initial visit, at 3 and 12 months.

Results : IOP was significantly reduced with surgery in both groups at all follow up times (p<0,05). No significant differences were found in IOP between groups at any follow up time. The were no sight threatening adeverse events or complications in either group. There was at least one complication (ie transient hypotony, narrow chamber, transient loss of 2 lines in visual acuity, Seidel positive…) in 32 (67%) eyes after NPDS and in 43 (86%) in the ExPress group (p=0.024). There was no statistically significant difference in the frequency of individual complications between the groups with the only exception of conjunctival fistula (Seidel +) which appeared, transiently and without the need for surgical repair, in 9 cases (18%) in the Express Group and was not present in any case in the DS group (p=0.002). The endothelial count loss was 259,2 + 340,7 (9,7 + 11,5%) and 317,4 + 417,4 (12,3 + 12,9 %) cell/mm² at 3 months; and 310,7 + 357,1 (11,7 + 10,7%) and 242,9 + 3,74 cell/mm² (9,4 + 12,7 %) at 12 months in the Ex-Press and DS groups, respectively, with no significant differences between the groups.

Conclusions : Both Ex-Press implant and DS were effective and safe, only with mild complications and similar endothelial count loss.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.