Scleral Allograft-Reinforced Cyclodialysis Combined with Phacoemulsification or Performed as a Standalone Procedure: 24-Month Outcomes from the Multicenter CREST Study
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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.
Trial Registration
ClinicalTrials.gov NCT05506423 .
Plain Language Summary
Glaucoma damages the optic nerve, usually because pressure inside the eye is too high. A newer operation opens a small channel to a natural drainage route inside the eye and holds it open with thin pieces of biocompatible donor tissue. It spares the surface of the eye, so other operations remain possible later. We asked how well the procedure works after two years. We studied 208 eyes at 17 centers that returned for their two-year visit: 176 done with cataract surgery and 32 done as a standalone procedure. We measured eye pressure and drop use and checked for long-term safety. With cataract surgery, pressure decreased from about 18 to 15 mmHg (millimeters of mercury, the standard measurement for eye pressure) and drop use by about half a drop; eyes starting at the highest pressures improved most, falling about 9 mmHg. Done alone, pressure decreased from about 20 to 14 mmHg and drop use by about one drop. The share of eyes needing no drops at all roughly doubled with cataract surgery, from about a quarter to about a half, and rose from almost none to about a third when done alone. No eye developed dangerously low pressure or fluid behind the retina. About one-in-four eyes treated alone needed a further pressure-lowering procedure within two years, against about one-in-twenty treated with cataract surgery. The procedure meaningfully lowered pressure and drop use over two years without the complications that ended earlier versions of this promising surgery.
Key Summary Points
Why carry out this study?
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Eyes needing cataract surgery with better pressure control, and eyes needing pressure control alone, are managed very differently, yet 2-year data on allograft-reinforced cyclodialysis in both settings have not been reported together.
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We asked: how much do pressure and medication burden fall by 24 months in each setting, how often further surgery is needed, and how safe is it?
What was learned from the study?
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When performed at the same time as cataract surgery, pressure decreased 3.1 mmHg and medications by 0.5, and the reductions rose steeply with baseline pressure. The proportion of eyes on no glaucoma medication doubled, from 22.9% to 46.4%.
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When performed as a standalone procedure, pressure decreased 6.4 mmHg and medications by 1.2, and medication-free eyes rose from 4.3% to 30.4%, reflecting promising outcomes in refractory eyes.
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No eye developed clinical hypotony, choroidal effusion, or corneal decompensation, and endothelial cell loss was confined to the phacoemulsification-combined cohort. Freedom from reoperation at 24 months was 98.9% with cataract surgery and 84.4% standalone.
