Scleral Allograft-Reinforced Cyclodialysis Combined with Phacoemulsification or Performed as a Standalone Procedure: 24-Month Outcomes from the Multicenter CREST Study

Introduction: Acellular scleral allograft-reinforced cyclodialysis is a bio-interventional surgery (BIOS) to lower intraocular pressure (IOP). We report 2-year efficacy and safety outcomes when the procedure is performed in combination with phacoemulsification and as a standalone procedure in eyes with open-angle glaucoma. Methods: Analysis of the multicenter CREST real-world evidence study of eyes undergoing allograft-reinforced cyclodialysis with AlloFlo™ Uveo (Iantrek, Inc., White Plains, NY; NCT05506423 ). Eyes attending the Month-24 visit were analyzed: 176 eyes undergoing phaco-combined surgery (Cohort 1) and 32 standalone eyes (Cohort 2). Values recorded after secondary procedures censored. Cohort 1 only was stratified by low, moderate, or high baseline IOP (≤ 15, 16-20, ≥ 21 mmHg). Results: A total of 176 eyes in Cohort 1 and 32 in Cohort 2 were analyzed. In Cohort 1, IOP decreased 3.1 mmHg at Month 24 from a baseline of 18.0 (-12.5%; p < 0.001), and medications decreased 0.5 from 1.5 (p < 0.001); medication-free eyes rose from 22.9% to 46.4% (p < 0.001). IOP changes in the low, moderate, and high baseline tiers were +0.9 (+7.8%), -3.0 (-16.3%), and -9.2 (-36.1%) mmHg; medication changes were -0.8, -0.6, and +0.1. In Cohort 2, IOP decreased 6.4 mmHg from 20.0 (-27.1%; p < 0.001), and medications decreased 1.2 from 2.8 (p = 0.004); medication-free eyes rose from 4.3% to 30.4% (p = 0.031). Secondary IOP-lowering procedures were performed in 5.1% of Cohort 1 eyes and 28.1% of Cohort 2. Kaplan-Meier freedom from reoperation was 98.9% and 84.4%. No eye developed clinically significant hypotony or choroidal effusion, and there were no allograft-related vision-threatening adverse events. Conclusion: Allograft-reinforced cyclodialysis effectively lowered IOP and medication use through 24 months.