Ab-Interno Gelatin Stent Procedure in Combination With Mitomycin-C for Treatment of Glaucoma: 12-Month Results
Purpose
To establish the safety and efficacy of a standalone minimally-invasive ab-interno gelatin stent procedure in combination with mitomycin C in reducing IOP and glaucoma medications in patients presenting with glaucoma. Mean IOP, IOP change, reduction in medications, and safety were recorded in 79 subjects through 12 months.
Methods
In this prospective, non-randomized, multi-center study, outside of the USA, safety and efficacy parameters were evaluated using IOP, visual acuity, and safety. Patients were diagnosed with moderate to severe glaucoma. Types of Glaucoma included POAG, Pigmentary, and Pseudoexfoliative. A trans-scleral gelatin stent is placed through a corneal incision using a preloaded injector. Once in place, the permanent implant is designed to connect the anterior chamber to the subconjunctival space, creating an ab-interno bleb while bypassing potential outflow barriers. Effectiveness was assessed by comparing medicated baseline IOP and IOP lowering medications to postoperative values through 12 months.
Results
No major adverse events were reported, and 1 patients was converted to Trabeculectomy procedure through 12 months. The mean preoperative (best medicated) IOP was 22.7 mmHg. The mean postoperative IOPs were: 14.4 at 6 months, 14.3 at 9 months, and 13.4 at 12 months. The mean decrease in IOP was -8.4 (37% reduction) at 6 months, -8.4 mmHg (37% reduction) at 9 months, and -9.3 (41% reduction) at 12 months. At 6, 9, and 12 month visits anti-glaucomatous medications were reduced by 64% from the preoperative mean of 3.3 (patients not washed out pre-surgery).
Conclusion
The preliminary results for this subconjunctival gelatin implant are promising and seem to provide a relatively safe method for controlling IOP in patients with open-angle glaucoma. In eyes with longer follow up, there appears to be a sustained IOP lowering effect of this implant. Long term data to follow.