Prospective Evaluation of XEN Gel Implant in Eyes With Pseudoexfoliative Glaucoma.
Mansouri Kaweh, Gillmann Kevin, Rao Harsha L, Guidotti Jacopo, Mermoud André
AI Summary
This study found the XEN gel implant similarly effective and safe for reducing eye pressure in both pseudoexfoliative and primary open-angle glaucoma, making it a viable treatment option for both conditions.
Abstract
Purpose
The main purpose of this study was to compare the safety and efficacy of XEN gel implant surgery in patients with pseudoexfoliative glaucoma (PEXG) and primary open-angle glaucoma (POAG).
Setting
This was a prospective, interventional study in a tertiary glaucoma center.
Methods
Fifty-seven eyes (43 patients) with POAG and 53 eyes (42 patients) with PEXG with uncontrolled intraocular pressure (IOP) despite medical treatment underwent combined XEN+cataract surgery or standalone XEN surgery. Mean IOP, mean number of medications at 1-year follow-up, needling rates, and incidence of adverse effects (AEs) were analyzed. Complete success, defined as an IOP <16 mm Hg without medications at 1 year, was also analyzed.
Results
Combined XEN+cataract surgery was performed in 72% of POAG and 75% of PEXG eyes (P=0.674), the remainder underwent standalone XEN surgery. Patient characteristics were similar between the 2 groups except for higher age for the PEXG patients (78.5±8.5 vs. 71.3± 8.7 y; P<0.001). Mean medicated IOP was 19.8±5.8 (POAG) and 19.7±8.2 (PEXG) at baseline (P=0.98) and 13.9±4.6 (-29.8%) and 13.6±4.3 mm Hg (-31%) at 1 year (P=0.87), respectively (P<0.01). Mean medications dropped from 1.9±1.6 (POAG) and 2.0±1.3 (PEXG) preoperatively to 0.4±0.8 and 0.5±0.8, respectively at 1 year (P<0.001). A total of 42% (POAG) and 63% (PEXG) eyes achieved complete success (P=0.06) at 1 year. Needling was performed in 36.8% (POAG) versus 37.7% (PEXG) (P=0.923).
Conclusions
The XEN gel implant as a standalone or combined procedure demonstrated similar efficacy and safety results in PEXG and POAG eyes.
MeSH Terms
Shields Classification
Key Concepts5
The mean medicated intraocular pressure (IOP) at 1 year was 13.9±4.6 mm Hg (-29.8% reduction from baseline) in eyes with primary open-angle glaucoma (POAG) and 13.6±4.3 mm Hg (-31% reduction from baseline) in eyes with pseudoexfoliative glaucoma (PEXG) (P=0.87) following XEN gel implant surgery or combined XEN+cataract surgery in a prospective, interventional study of 57 eyes with POAG and 53 eyes with PEXG.
The mean number of medications dropped from 1.9±1.6 preoperatively to 0.4±0.8 at 1 year in eyes with primary open-angle glaucoma (POAG) and from 2.0±1.3 preoperatively to 0.5±0.8 at 1 year in eyes with pseudoexfoliative glaucoma (PEXG) (P<0.001) following XEN gel implant surgery or combined XEN+cataract surgery in a prospective, interventional study of 57 eyes with POAG and 53 eyes with PEXG.
Complete success, defined as an IOP <16 mm Hg without medications at 1 year, was achieved in 42% of eyes with primary open-angle glaucoma (POAG) and 63% of eyes with pseudoexfoliative glaucoma (PEXG) (P=0.06) following XEN gel implant surgery or combined XEN+cataract surgery in a prospective, interventional study of 57 eyes with POAG and 53 eyes with PEXG.
Needling was performed in 36.8% of eyes with primary open-angle glaucoma (POAG) versus 37.7% of eyes with pseudoexfoliative glaucoma (PEXG) (P=0.923) following XEN gel implant surgery or combined XEN+cataract surgery in a prospective, interventional study of 57 eyes with POAG and 53 eyes with PEXG.
The mean medicated intraocular pressure (IOP) at baseline was 19.8±5.8 mm Hg in eyes with primary open-angle glaucoma (POAG) and 19.7±8.2 mm Hg in eyes with pseudoexfoliative glaucoma (PEXG) (P=0.98) in a prospective, interventional study of 57 eyes with POAG and 53 eyes with PEXG.
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