One-Year Real-World Outcomes of Ab-Externo Gel Stent Placement From the EXPAND Study.
Francis Brian A, Vera Vanessa, Kim Joshua, Basha Mahdi M, Lum Bryant, Grayson Douglas, Vold Steven, Balaram Mini, Simonyi Susan, Ansari Husam
AI Summary
Ab-externo gel stent implantation effectively reduced intraocular pressure (34%) and medication burden (61%) in glaucoma patients, with transient hypotony (28%) as the main adverse event, expanding surgical options.
Abstract
Précis: In the real-world, retrospective, EXPAND study of consecutive adults with glaucoma, ab-externo gel stent implantation effectively lowered intraocular pressure (34%) and the medication burden (61%), with transient/self-resolving hypotony as the most frequent adverse event (28%).
Purpose
To assess effectiveness and safety of ab-externo gel stent (GS) implantation in glaucoma.
Methods
Multicenter, real-world, retrospective study. Consecutive adults with glaucoma and ab-externo GS implantation (with/without phacoemulsification or open/closed conjunctiva) ≥12 months before study entry. Data were extracted between the baseline/preoperative and last follow-up visit or date of secondary surgical intervention (SSI). Primary effectiveness endpoint: proportion of primary eyes (first eye in bilaterally implanted patients) at month 12 (M12) achieving ≥20% intraocular pressure (IOP) reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or SSI. Secondary effectiveness endpoints included complete success (IOP ≤18 mm Hg and ≥20% IOP reduction from medicated baseline without medication, clinical hypotony, or SSI); qualified success (same but without medication increase); and needling rate. Key safety endpoints (all eyes): intraoperative complications, postoperative adverse events (AEs), and SSIs.
Results
The safety population included 466 eyes; 80.7% received the GS alone and 85.0% were implanted with closed conjunctiva. At M12, 39.1% of all primary eyes (N=413) and 54.9% of primary eyes with IOP and medication data at baseline and M12 (N=213) achieved the primary endpoint. At M12 among all primary eyes, the complete success, qualified success, and needling rates were 33.5%, 56.5%, and 28.6%. Most eyes (97.9%) had no intraoperative complications. The most frequent postoperative AE was transient/self-resolving hypotony (IOP <6 mm Hg; 28.1%). Sixty-nine (14.8%) eyes required an SSI.
Conclusions
Ab-externo GS placement effectively lowered IOP and the medication count without unexpected complications/AEs, expanding implantation options based on patients' needs and surgeons' preferences.
MeSH Terms
Shields Classification
Key Concepts5
In a real-world, retrospective study (EXPAND study) of 466 eyes from consecutive adults with glaucoma, ab-externo gel stent implantation effectively lowered intraocular pressure by 34% and reduced medication burden by 61%.
In the EXPAND study, a real-world, retrospective study of 466 eyes from adults with glaucoma undergoing ab-externo gel stent implantation, the most frequent postoperative adverse event was transient/self-resolving hypotony (IOP <6 mm Hg), occurring in 28.1% of eyes.
At 12 months, 39.1% of all primary eyes (N=413) and 54.9% of primary eyes with IOP and medication data at baseline and 12 months (N=213) achieved the primary endpoint of ≥20% intraocular pressure reduction from baseline without medication increase, clinical hypotony, vision loss to counting fingers, or secondary surgical intervention following ab-externo gel stent implantation in adults with glaucoma.
Among all primary eyes (N=413) of adults with glaucoma who received ab-externo gel stent implantation, the complete success rate (IOP ≤18 mm Hg and ≥20% IOP reduction from medicated baseline without medication, clinical hypotony, or secondary surgical intervention) was 33.5% at 12 months.
In a real-world, retrospective study of 466 eyes from adults with glaucoma who underwent ab-externo gel stent implantation, 14.8% of eyes required a secondary surgical intervention.
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