The Ex-PRESS glaucoma shunt versus non penetrant deep sclerectomy in open-angle glaucoma: a prospective randomized study, Interim results.

Abstract

Purpose: Purpose: Express device and non-penetrant deep sclerectomy (NPDS) are effective at reducing intraocular pressure (IOP) but have not been compared in combined surgery. This are interim results of a prospective, multicenter, single-blinded, randomized trial to evaluate efficacy and safety of Ex-PRESS implant vs. NPDS combined with cataract surgery at 12 months.

Methods: Methods: Eyes were randomly assigned to either Ex-PRESS or NPDS. Main outcomes measures were mean IOP, success rate, postoperative medications and incidence of complications. Complete success was defined as an IOP of < 18 mmHg without medications. Total sample size is 100 subjects, 50 in each group. Double tail Student t test was used to compare both groups. Inclusion criteria: Primary open angle uncontrolled glaucoma. Exclusion criteria: secondary glaucoma other than pigmentary and pseudoexfoliation; previous glaucoma surgery, myopia > 6 diopters, hyperopia > 5 diopters, tilted discs or advanced glaucoma. Interventions: Phacoemulsification with Ex-PRESS device or NPDS. Postoperative visits: day 1, weeks 1, 2 and 3 and months 1, 3, 6 and 12.<br /> Adverse events were checked in every visit. Criteria for withdrawal were surgical complications that could influence the result or patient’s wish.

Results: Results: As of now 62 of the eyes included in the study have completed over 3 months of follow up. ExPRESS group represented 51% (32 cases) and NPDS 49% (30 cases). Mean age (SD) was 76 (±) years old. Mean preoperative IOP was 19 (±4) mmHg. Mean postoperative IOP in the ExPRESS and in the NPDS group, respectively: at month 3 was 12.28 (±4.5) mmHg vs. 12.6 (±4.8) mmHg; at month 6 was 13.2 (±4.6) mmHg vs. 12.9 (±3.8) mmHg and at month 12 was 13.4 (±4.7) mmHg vs. 13.5 (±3.6) mmHg. IOP was significantly reduced with surgery in both group at all follow up times (p<0,05). No significant differences were found in IOP between groups at any follow up time. At month 6 complete success rates was 85% and 84% in ExPRESS and NPDS groups respectively. Complications: No major complications occurred in either group.

Conclusions: CONCLUSIONS: In this interim analysis of combined cataract and glaucoma surgery, the ExPRESS implant has been observed to be as effective and safe to reduce IOP as NPDS with similar levels of postoperative interventions and complications.