Abstract
Purpose :
The XEN gel stent was approved for ab-interno implantation and has been used for >10 years. Recently, surgeons worldwide have developed and adapted a novel approach, implanting the gel stent ab externo. This is the first evaluation of real-world data of the gel stent when placed ab externo.
Methods :
In this multicenter, retrospective, chart review, consecutive ≥18-year old patients with elevated intraocular pressure (IOP) requiring surgical intervention were included. Patients underwent ab-externo placement of gel stent alone or combined with phacoemulsification, with or without opening of the conjunctiva, ≥12 months before study inclusion. Mean IOP and number of topical IOP-lowering medications at baseline and 12 months were recorded, as well as ocular adverse events (AEs). Available preoperative, operative, and postoperative data were collected.
Results :
The analysis included 472 eyes from 412 patients; 382 (80.9%) eyes received the gel stent alone. Mean age was 75.1 years (range, 21-98) and 54.7% of patients were female. Month-12 data was available for 193 eyes. Mean (standard deviation [SD]) IOP decreased from a medicated baseline of 20.8 (7.6) mmHg to 14.9 (5.1) mmHg at 12 months, a mean reduction of ~6 mmHg (~28%). 181 (93.8%) eyes required topical IOP-lowering medications at baseline vs 110 (57.0%) at 12 months, including 11 and 3 patients who also required oral therapy, respectively. The most frequent AEs were transient, self-resolving hypotony (<6 mmHg – n=66, 22.8%), uncontrolled IOP requiring secondary surgical intervention (n=39, 13.5%), bleb leak (n=37, 12.8%), implant exposure/extrusion/conjunctival erosion (n=20, 6.9%) and choroidal effusion/hemorrhage/mixed effusion hemorrhage (n=24, 5.9%).
Conclusions :
When placed via the novel ab-externo technique, the gel stent effectively lowered IOP and the IOP-lowering medication count, with a predictable and acceptable safety profile.
This is a 2021 ARVO Annual Meeting abstract.