Purpose: To evaluate the efficacy and safety of the XEN63 Gel Stent in patients with open-angle glaucoma (OAG).
Methods: Prospective, nonrandomized, open-label, not-controlled, and single center study conducted on OAG patients who underwent glaucoma surgery with the XEN63 gel stent. The main outcome measure was intraocular pressure (IOP). Secondary end-points were number of topical ocular hypotensive drugs, percentage of patients achieving an IOP reduction ⩾20%, and treatment-related adverse events.
Results: Eleven eyes from 11 patients were treated with XEN 63. Mean (95% confidence interval, CI) age was 78.8 (73.7-85.9). Two eyes (18.2%) underwent XEN alone, while nine eyes (81.8%) underwent combined XEN + cataract extraction (phacoemulsification). The median (95% CI) IOP reduction was 17.7% (-13.3% to 34.9%). At the end of the study 9 (81.8%) eyes had an IOP ⩽ 18 mm Hg, six of them without treatment. Six (54.6%) eyes obtained an IOP reduction ⩾20%. Compared to baseline, there was a significant reduction in the number of ocular hypotensive drugs (p = 0.0039). There were no treatment-related serious adverse events. Early postoperative complications included diplopia (1), blood in endothelium (2), ocular hypertension (1), corneal edema (1), folds in Descemet's membrane (1), and contact between the implant and the iris (1). All the adverse events were successfully solved without sequalae. One eye required bleb needling.
Conclusion: The XEN63 implant significantly reduced both IOP and the amount of ocular hypotensive medications while maintaining a good safety profile.
Keywords: Open-angle glaucoma; aqueous humor dynamics; glaucoma incisional surgery; tube shunts.