Ab-Externo MicroShunt vs. Trabeculectomy in Primary Open-Angle Glaucoma: 5-Year Safety Results from a Randomized,...

Area of Science:

• Ophthalmology
• Glaucoma Surgery
• Medical Device Safety

Background:

• Primary open-angle glaucoma (POAG) is a leading cause of irreversible blindness.
• Effective surgical interventions are crucial for managing POAG and preventing vision loss.
• Long-term safety data comparing MicroShunt implantation and trabeculectomy are essential for clinical decision-making.

Purpose of the Study:

• To compare the long-term safety and efficacy of MicroShunt implantation versus trabeculectomy in POAG patients.
• To evaluate adverse events (AEs), intraocular pressure (IOP) control, and medication use over a 5-year period.
• To assess the cumulative incidence of sight-threatening AEs following each surgical procedure.

Main Methods:

• A 3-year observational extension of a 2-year prospective randomized trial.
• Inclusion of 279 patients with POAG undergoing MicroShunt or trabeculectomy, both augmented with mitomycin C.
• Recording of AEs, IOP, and medication use at 36, 48, and 60 months post-randomization.

Main Results:

• Both procedures showed favorable safety profiles over 5 years.
• Trabeculectomy achieved a greater reduction in IOP compared to MicroShunt (45% vs. 26%).
• MicroShunt had a higher incidence of increased IOP requiring treatment but less hypotony and fewer secondary interventions for hypotony compared to trabeculectomy.

Conclusions:

• MicroShunt implantation and trabeculectomy are safe and effective long-term surgical options for POAG.
• The choice between procedures may depend on balancing the risk of hypotony versus the need for IOP-lowering treatment.
• Most AEs were not sight-threatening and did not require reoperation.