Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma

Abstract

Purpose To evaluate the effectiveness of an ab interno subconjunctival gelatin implant as primary surgical intervention in reducing intraocular pressure (IOP) and IOP-lowering medication count in medically uncontrolled moderate primary openangle glaucoma (POAG). Methods In this prospective, non-randomized, open-label, multicenter, 2-year study, eyes with medicated baseline IOP 18-33 mmHg on 1-4 topical medications were implanted with (phaco + implant) or without (implant alone) phacoemulsification. Changes in mean IOP and medication count at months 12 (primary outcomes) and 24, clinical success rate (eyes [%] achieving ≥ 20% IOP reduction from baseline on the same or fewer medications without glaucoma-related secondary surgical intervention), intraoperative complications, and postoperative adverse events were assessed. Results The modified intent-to-treat population included 202 eyes (of 218 implanted). Changes (standard deviation) in mean IOP and medication count from baseline were − 6.5 (5.3) mmHg and − 1.7 (1.3) at month 12 and − 6.2 (4.9) mmHg and − 1.5 (1.4) at month 24, respectively (all P < 0.001). Mean medicated baseline IOP was reduced from 21.4 (3.6) to 14.9 (4.5) mmHg at 12 months and 15.2 (4.2) mmHg at 24 months, with similar results in both treatment groups. The clinical success rate was 67.6% at 12 months and 65.8% at 24 months. Overall, 51.1 (12 months) and 44.7% (24 months) of eyes were medication-free. The implant safety profile compared favorably with that published for trabeculectomy and tube shunts. Conclusions The gelatin implant effectively reduced IOP and medication needs over 2 years in POAG uncontrolled medically, with an acceptable safety profile. ClinicalTrials.gov registration number: NCT02006693 (registered in the USA).

Effect of the outer stent position on efficacy after minimally invasive transscleral glaucoma gel stent implantation

“…Overall success rates and efficacy (IOP and number of medications) results are comparable to the recently published APEX study (Reitsamer et al. ). There are no data yet published establishing whether a deep or superficial implantation in the conjunctiva is advantageous for an efficacious patient outcome after XEN‐GGM implantation.…”

Technique of Xen Implant Revision Surgery and the Surgical Outcomes: A Retrospective Interventional Case Series

“…Data published thus far support the Xen implant being a safe and effective approach to lowering IOP and reducing drop dependency in patients with glaucoma [1][2][3][4][5][6][7][8][9][10][11][12][13][14]. Although these reports show complications rates to be lower than those associated with traditional glaucoma surgery, it is standardly accepted that a proportion of eyes will require bleb needling in the post-operative period and that despite this some implants will fail due to progressive scarring of the conjunctiva around the stent opening that is unresponsive to slit lamp needling and antimetabolite injections [12].…”

Comparison of the effectiveness of the XEN microstent in the treatment of different types of glaucoma

“…The XEN microstent is designed to bypass the transtrabecular out ow pathway whereby reducing IOP. Since its initial description, a number of reports have been published on the e cacy and safety pro le of the XEN microstent for the treatment of POAG [21,18,22]. In summary, implantation of the XEN microstent can signi cantly reduce IOP and the amount of IOP-lowering eye drops applied, resulting in acceptable success rates in POAG after 12 and 24 months.…”

“…In summary, implantation of the XEN microstent can signi cantly reduce IOP and the amount of IOP-lowering eye drops applied, resulting in acceptable success rates in POAG after 12 and 24 months. Reitsamer and colleagues already showed in their one and two-year multicenter study (APEX study) that IOP and required medication can be reduced effectively by implantation of the XEN microstent either alone or in combination with phacoemulsi cation and posterior chamber lens implantation [21] Some groups even reported on achieving lower mean postoperative IOP values of around 12 mmHg when starting from a lower initial mean level at baseline before surgery [23].…”