CREST Registry study evaluates outcomes of biointerventional procedures in patients with OAG
The CREST Registry study reported on the safety and effectiveness outcomes of microinvasive cyclodialysis clef formation with the CycloPen system, followed by scleral reinforcement with AlloFlo Bio-Tissue implantation, according to Iantrek.
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Iantrek announced 1-year results late last year for the first 100 eyes enrolled in the company’s CREST Registry, a real world, prospective, observational study evaluating the outcomes of biointerventional procedures in patients with open angle glaucoma (OAG).1 The study, “One-Year Safety and Effectiveness of Bio-Interventional Cyclodialysis and Scleral Reinforcement in Open-Angle Glaucoma Patients,” was published in Clinical Ophthalmology, according to a news release.
The CREST Registry study reported on the safety and effectiveness outcomes of microinvasive cyclodialysis clef formation with the CycloPen system, followed by scleral reinforcement with AlloFlo Bio-Tissue implantation. The study is the largest of its kind to report on long-term results of this approach using surgical micro-instrumentation and allogeneic bio tissue to increase aqueous outflow for the lowering of intraocular pressure (IOP).1
“While the majority of the outflow enhancing surgical procedures augment the trabecular outflow pathway, few surgical options exist for the other major outflow pathway – the uveoscleral pathway,” the study authors, led by Tsontcho Ianchulev, MD, of New York Eye and Ear of Mount Sinai, New York, New York, and founder of Iantrek, stated.2 “The cornerstone of surgical outflow enhancement of the uveoscleral pathway remains the cyclodialysis procedure.”
The bio-interventional technique works to enhance uveoscleral outflow – 1 of the 2 natural outflow pathways in the eye – by creating an internal cyclodialysis channel, which is bio-reinforced for maintenance of long-term patency.1
“It has been well established that implant material properties are critical to the healing, rejection, and inflammatory reaction of the surrounding tissues,” the study authors reported.2 “One of the most salient determinants of implant fibrosis, granulomatous inflammation, and macrophage activation is the stiffness mismatch between the implant and the physical/elastic properties of the surrounding tissues. Minimizing this gap by matching the stiffness of the implant to the surrounding tissue can improve implant biocompatibility.”
Key findings from the study include IOP reduction, medication reduction, and safety. Patients with a baseline IOP > 21 mmHg experienced a 12-month mean IOP decrease of 39.7%. Additionally, the average number of IOP-lowering medications at 12-months post operation decreased from 1.4 ± 1.3 to 0.8 ± 0.9, with 81.9% of patients achieving an IOP of ≤18 mmHg without additional medications needed. As for safety, the procedure demonstrated a favorable safety profile in the CREST Registry study, with a low rate of postoperative complications. There were also no vision threatening adverse events, with 3.2% of patients requiring secondary glaucoma surgery within the 12-month follow up period in order to achieve target IOP.1
“In conclusion, our results inform an improved technique and advancement of the cyclodialysis surgical paradigm with a novel bio-interventional approach using allograft scleral reinforcement,” the study authors stated.2 “This can achieve sustained and enhanced internal outflow through the uveoscleral pathway and provide much-needed treatment options for IOP-lowering in glaucoma patients.”
References:
Iantrek announces peer-reviewed publication highlighting 12-month safety and effectiveness results for its bio-interventional uveoscleral outflow technology in open-angle glaucoma patients. News release. Global Newswire. December 10, 2024. Accessed February 7, 2025. https://www.globenewswire.com/news-release/2024/12/10/2994513/0/en/Iantrek-Announces-Peer-Reviewed-Publication-Highlighting-12-Month-Safety-and-Effectiveness-Results-for-its-Bio-Interventional-Uveoscleral-Outflow-Technology-in-Open-Angle-Glaucoma-.html
Ianchulev T, Weinreb RN, Clavo EA, et al. Bio-interventional cyclodialysis and allograft scleral reinforcement for uveoscleral outflow enhancement in open-angle glaucoma patients: 1-year clinical outcomes. Dovepress. 2024;2024:3605-3614. doi:https://doi.org/10.2147/OPTH.S496631
