One-year data from an ongoing study demonstrates the safety and effectiveness of bio-reinforced cyclodialysis with scleral allograft in managing open-angle glaucoma (OAG) in patients undergoing cataract surgery, study investigators reported recently. The data from the first 117 eyes enrolled in the CREST Registry was published in the December issue of Clinical Ophthalmology.

The bio-reinforced cyclodialysis procedure combines an ab interno cyclodialysis, created with the CycloPen system (Iantrek) with visco-cycloplasty and reinforcement using a homologous scleral allograft for maintenance of long-term patency. It is intended to enhance uveoscleral outflow to reduce IOP. 

Investigators reported that at 12 months the mean IOP was reduced by 39.7% from a baseline of >21 mmHg. The average number of IOP-lowering medications decreased from 1.4±1.3 to 0.8±0.9 at 12 months, and 81.9% of patients achieved an IOP ≤18 mmHg without the need for additional medications. The procedure also demonstrated a favorable safety profile, with a low rate of postoperative complications. Notably, there were no vision-threatening adverse events, and only 3.2% of patients required secondary glaucoma surgery within the 12-month follow-up period to achieve target IOP. Visual outcomes were also positive, with an average improvement in BCVA from 20/40 to 20/28.

“Iantrek’s micro-interventional technology opens new horizons in interventional glaucoma,” said Robert N. Weinreb, MD, of the Shiley Eye Institute, University of California San Diego, in La Jolla, California, a principal investigator on the study. “Cyclodialysis creation, durable cleft maintenance, and high-precision bio-tissue trephination in a hardware-free surgical approach can be a game-changer.”