Long term results of non-penetrating deep sclerectomy with Esnoper V-2000 implant in a tertiary center of Ophthalmology

Abstract

Introduction: Nonpenetrating deep sclerectomy (NPDS) is one of the surgical procedures used for lowering intraocular pressure (IOP) in patients with uncontrolled open-angle glaucoma. This surgery can be enhanced with the use of antimetabolites as well as implants - devices that are placed to facilitate the aqueous outflow by maintaining the virtual space created after removing the deep scleral flap. The purpose of this study was to report the long-term efficacy and safety of NPDS with adjunctive mitomycin C (MMC) and a nonabsorbable hydroxyethyl methacrylate implant (Esnoper V-2000) in our institution.

Methods: This is a retrospective study. Inclusion criteria were: adjunctive use of MMC and Esnoper V2000; follow-up time post-NPDS≥24 months; absence of additional glaucoma surgery within the first 24 months post-NPDS. Of 55 NPDS surgeries performed between April 2013 and January 2017 in our institution, 39 eyes (35 patients) met the inclusion criteria. Primary outcome was surgical success, defined as IOP at last follow-up observation ≤18mmHg and IOP reduction rate (IOP-RR)≥20%, either with (relative) or without (absolute) need of IOP-lowering drugs, and without additional surgery. Secondary outcomes were change in number of antihypertensive drugs, Nd:YAG goniopuncture (Nd:YAG GP) rate, and need for additional glaucoma surgery.

Results: Mean patient age at NPDS was 69.0 (±11.3) years. Mean pre-NPDS IOP was 21.6 (±6.0) mmHg on median 4 (1) IOP-lowering drugs. Mean follow-up time post-NPDS was 40.3 (±14.2) months. Median IOP at 2-years (M24) and last-follow-up was 14.0 (6.0) mmHg, on a median number of 1 (2) IOP-lowering drugs. Statistically significant reductions in median IOP and IOP-lowering drugs were observed at M24 and at last follow-up compared to baseline (p<0.001). Success rate at M24 was 61.5% (25.6% relative and 35.9% absolute success) and 56.4% at last follow-up. Nd:YAG GP rate was 35.9%, performed at a mean time of 14.4 (±6.5) months post-NPDS. Two eyes (5.1%) needed additional glaucoma surgery after M24.

Conclusions: In our study, NPDS with adjunctive MMC and Esnoper V-2000 resulted in a significant reduction in IOP and number of IOP-lowering drugs over the long term, with a relatively high surgical success rate. Our patients could possibly benefit from a higher rate of Nd:YAG GP which was lower than reported in other studies. The need for additional glaucoma surgery is low in NPDS eyes.