A recent study evaluated the safety and efficacy of bio-interventional cyclodialysis with allograft scleral reinforcement for enhancing uveoscleral outflow in open-angle glaucoma patients. This approach combined a minimally invasive ab-interno approach with a biologically compatible scaffold to achieve significant intraocular pressure reduction while minimizing medication use.
The study included 117 eyes from 89 open-angle glaucoma (OAG) patients with mild to severe disease who underwent combined cataract surgery and bio-interventional cyclodialysis. During the procedure, the ab-interno approach created a reservoir for uveoscleral outflow, and the cleft was reinforced with an allograft scleral bio-scaffold to maintain its patency and prevent closure. The primary outcome measure was intraocular pressure (IOP) reduction and change in the number of IOP-lowering medications, while the secondary outcome measure concerned safety, including adverse events and visual acuity changes.
The investigators found mean IOP decreased by 27.1% from baseline at 12 months (20.2 ± 6.0 mmHg to 13.9 ± 3.9 mmHg). In eyes with baseline IOP ≥21 mmHg, IOP dropped by 39.7%. Patients also required fewer medications postoperatively (1.4 ± 1.3 to 0.8 ± 0.9), and 81.9% achieved an IOP ≤18 mmHg without an increase in medications. “The 6.3mm reduction in mean medicated IOP from baseline through 12 months post-operatively was statistically significant,” the researchers reported in their Clinical Ophthalmology article. Best-corrected visual acuity (BCVA) improved from 20/40 to 20/28.
The use of biocompatible allografts minimizes the risk of tissue reaction or implant migration, which is a common concern with synthetic devices. Indeed, the mean IOP reduction with bio-reinforced cyclodialysis (6.3 mmHg) exceeded outcomes reported for commonly used trabecular stents such as iStent (2.2 mmHg) and Hydrus (3.1 mmHg), the researchers noted.
They wrote: “Control of foreign body reaction, fibrovascular response and premature cyclodialysis ‘restenosis’ and closure can be transformational to the clinical utility and application of one of the oldest conventional glaucoma surgeries. In the age of new interventional approaches for IOP lowering, combining two well-established and known surgical modalities, namely cyclodialysis and scleral allograft reinforcement, in a synergistic surgical framework to create improved ab-interno intervention for uveoscleral outflow enhancement is compelling.”
No vision-threatening complications or significant adverse events were reported. Transient hypotony and macular edema occurred in isolated cases but resolved without long-term impact. Of the safety profile, the investigators noted: “Both the cyclodialysis procedure and the scleral reinforcement procedures were well tolerated, demonstrating a MIGS-like safety profile without interfering with the outcomes and the follow-up of phaco-cataract surgery.”
Further randomized controlled trials are needed to confirm these results and explore long-term outcomes.
A full list of author disclosures can be found in the published research.