scleral Bio-Reinforced Cyclodialysis Lowers IOP, Offers Promising Option to Traditional Glaucoma surgery
A new study published in ophthalmology Science demonstrates that scleral bio-reinforced cyclodialysis, combined with cataract surgery, substantially lowers intraocular pressure (IOP) in patients with glaucoma by enhancing uveoscleral outflow. The findings suggest a less invasive option for managing the condition compared to traditional procedures like trabeculectomy or tube shunts.
The procedure, evaluated in a single-center prospective case series, showed that 74% of eyes achieved a 20% or greater reduction in IOP without requiring an increase in glaucoma medication over a 24-month period. This represents a ample advancement in IOP control for patients often facing a complex treatment landscape.
The study involved 31 eyes diagnosed with primary open-angle glaucoma and visually notable cataracts. Each patient underwent phacoemulsification, followed by intraocular lens (IOL) implantation, and then the uveoscleral outflow enhancement surgery. This involved creating a cyclodialysis – a small opening – and reinforcing it with a scleral allograft, a tissue graft from the sclera.
“The uveoscleral pathway is widely recognized as an crucial anatomical target for intraocular pressure reduction,” explained robert N. Weinreb,MD,chair and distinguished professor of ophthalmology at the University of California,San Diego. “These 2-year data reinforce that understanding and highlight the potential of this innovative technology.”
Researchers focused on the proportion of eyes achieving a 20% or greater IOP reduction as the primary endpoint. Secondary endpoints included changes in medicated IOP and the number of IOP-lowering medications used. At the 24-month mark,the average IOP reduction was 34% compared to baseline measurements. Patients reduced their reliance on medication from an average of 1.4 IOP-lowering drugs at the start of the study to just 0.5 at the end. Baseline medicated IOP was 21.9 ± 4.92 mm Hg, decreasing to 13.8 ± 2.4 mm Hg after 24 months.
Notably, the procedure demonstrated a positive safety profile, with no serious ocular adverse events reported. This minimal complication rate positions scleral bio-reinforced cyclodialysis as a possibly attractive alternative to more invasive surgical interventions. The authors suggest the allograft plays a crucial role in modulating the wound-healing response and preventing fibrosis,an area ripe for further investigation.
“As MIGS evolves, these findings could contribute to the development of even more refined and individualized treatment strategies for patients with glaucoma,” the study authors wrote.
Thomas W. Samuelson, MD, of Minnesota Eye Consultants and Healio OSN Glaucoma Section Editor, offered his perspective on the study. He noted the intriguing IOP-lowering results and reassuring safety profile, emphasizing that the scleral spacer functions to maintain the patency of the cyclodialysis cleft, rather than acting as a “wick” for aqueous fluid. According to Samuelson, 96.8% of patients achieved an IOP of 18 mm Hg or less, and 80.6% reached an IOP of 15 mm Hg or less at 24 months. Visual acuity also improved significantly, from a baseline logMAR of 0.7 to 0.11.
Samuelson highlighted areas for future research, including the need for data on visual field mean deviation, IOP measurements at earlier postoperative time points (day 1 and week 1), and the stability of refractions in the weeks following surgery. he also pointed out a key benefit of this procedure: it keeps aqueous fluid within the eye, eliminating the risk of complications associated with bleb formation, such as infection or leakage.
While not anticipating this procedure to compete with canal-based surgeries for mild to moderate glaucoma, Samuelson believes it could become a valuable option for patients who have not responded to those treatments before considering more invasive procedures. The study’s findings represent a significant step forward in the ongoing quest for more effective and less invasive glaucoma treatments.
