Early Results of Microinvasive Ab Interno Gelatin Stent With Adjunctive Mitomycin C in Treatment of Open-Angle Glaucoma
Narrative Responses:
Purpose
To study the intraocular pressure (IOP) lowering effect of a micro-invasive ab-interno gelatin stent in combination with mitomycin C (MMC) in patients with uncontrolled open-angle glaucoma (OAG).
Methods
This was a prospective, non-randomized, multi-center trial in patients with OAG whose IOP’s were uncontrolled by medications. Fifty-three eyes were implanted with the XEN 45 micro-fistula device and followed for 9 months. The device was implanted through a self-sealing corneal incision using a preloaded injector after subconjunctival injection of MMC. With proximal end in the anterior chamber and the distal end in the subconjunctival space, the device allows for flow of aqueous humor to the subconjunctival space without a conjunctival incision or creation of a scleral flap. Mean IOP, IOP change from baseline, number of medications, and complications were recorded.
Results
The mean preoperative IOP was 22.7+5.1 mmHg on 3.1+1.1 medications. The mean postoperative IOP was 15.3+4.4 at 3 months, 14.8+4.3 at 6 months, and 12.0+5.3 at 9 months. The mean decrease in IOP was -7.4 mmHg (31% reduction) at 3 months, -8.1 mmHg (30% reduction) at 6 months, and -9.0 mmHg (44% reduction) at 9 months. Glaucoma medications were reduced by 68% at 9 months. No major adverse event or re-operation occurred. Three eyes were needled. No patients required additional glaucoma surgery through 9 months.
Conclusion
The XEN 45 micro-fistula implant with adjunctive MMC reduced IOP in patients with OAG over 9 months of follow-up without significant complications. This device may provide a minimally invasive surgical option in patients with OAG and IOP’s uncontrolled by medications.