Safety and efficacy of a modified suprachoroidal silicone tube shunt implant in primary open angle and pseudo-exfoliative glaucoma.

Abstract

Purpose: To assess the safety and efficacy of a modified suprachoroidal silicone tube (SST) shunt in patients with primary open-angle glaucoma (POAG) and pseudo-exfoliative glaucoma (PXG) in this experimental study.

Methods: In this single-center, retrospective longitudinal data analysis 66 eyes of 59 patients having POAG and PXG were included and treated with modified SST shunt in combination with cataract or as a stand-alone procedure. Pre- and postoperative intraocular pressure (IOP), best corrected visual acuity (BCVA), C/D ratio and ocular adverse events (AEs) were assessed in all participants.

Results: The average follow-up period was 18.56 ± 7.93 months. Mean baseline IOP reduced from 27.02 ± 5.43 mmHg to 13.23 ± 3.70 mmHg (p < 0.001). Mean number of ocular hypotensive medications reduced from 3.17 ± 0.89 to 1.83 ± 1.44 (p < 0.001). BCVA remained stable in 49 eyes (74.2%) throughout the follow-up period. Mean baseline BCVA of 0.73 ± 0.27 slightly declined to 0.68 ± 0.30 at the final follow-up (p < 0.001). Three adverse events of special interest (AESI) were observed hypotonic maculopathy, anterior chamber inflammation with pupillary membranes, and macular edema. None of these events was related to the SST shunt. Other complications such as intra and early postoperative hyphema in 3 and tube-iris contact causing slight corectopia in 2 cases were noted.

Conclusions: The surgical technique and device studied in this work demonstrated a good safety profile and signal of efficacy. This device may serve as a bridge between minimally invasive glaucoma surgeries (MIGS) and conventional filtering or episcleral tube shunt surgeries. A larger scale prospective trial is planned.