All Consecutive Ab Externo SIBS Microshunt Implantations With Mitomycin C: One-Year Outcomes and Risk Factors for Failure.

Purpose: To present the effectiveness, risk factors for surgical failure, and adverse events over 12 months in a consecutive diverse cohort of glaucoma patients who underwent solo or combined ab externo SIBS microshunt with mitomycin C (MMC) with or without previous subconjunctival surgery.

Design: Retrospective, consecutive, interventional case series.

Methods: Consecutive glaucomatous eyes on maximally tolerated medical therapy received ab externo SIBS microshunt with MMC implantation as a solo or combined procedure with phacoemulsification from July 2015 to January 2020. The primary outcome was the proportion of eyes at 12-months with the following: (1) no 2 consecutive intraocular pressures (IOPs) >17 mm Hg or clinical hypotony, without (complete success) or with (qualified success) glaucoma medications; and (2) ≥20% reduction from baseline IOP. Secondary outcomes included upper IOP thresholds of 14 and 21 mm Hg with and without a 20% IOP reduction from baseline, median IOP, medications, risk factors for failure, postoperative interventions, complications, and reoperations.

Results: A total of 436 eyes underwent surgery; 86 (20%) combined with phacoemulsification, 127 (29%) in eyes with refractory glaucoma, and 234 (51%) stand-alone procedures in non-refractory eyes. Complete success (6-17 mm Hg with no medications) was achieved in 64.0% of combined eyes, 58.1% of refractory eyes, and 74.8% of stand-alone non-refractory eyes; and qualified success rates (6-17 mm Hg with medications) were 90.7%, 84.7%, and 92.4% of eyes, respectively. At 12 months, 67% of eyes were medication free. Significant risk factors for failure included combined procedures in refractory eyes (hazard ratio [HR] = 3.2; 95% CI = 1.4-7.4), receiving <0.4 mg/mL of MMC (HR = 2.2; 95% CI = 1.6-3.1), refractory eyes (HR = 1.7; 95% CI = 1.2-2.5), combined procedures (HR = 1.6; 95% CI = 1.0-2.5), and each additional baseline medication class (HR = 1.3; 95% CI = 1.1-1.5). Postoperative complications occurred in 31% of eyes, and more often in those receiving ≥0.4 mg/mL MMC (odds ratio [OR] = 2.2, 95% CI 1.2-3.8). Needling occurred in 12% of eyes, with significantly higher frequency in refractory eyes (23%) and combined procedures (13%) compared to stand-alone (7%; P < .001). Revisions and reoperations occurred in 4% and 1.4% of eyes, respectively.

Conclusions: The 1-year follow-up data from this large and diverse cohort support promising rates of qualified and complete surgical success with decreased medication burden and few postoperative complications and interventions. Combined phacoemulsification, refractory glaucoma, and receiving <0.4mg/mL MMC were associated with reduced surgical success rates.