Ahmed Glaucoma Valve Surgery With Mitomycin-C

• Status: Completed
• Trial end date: 2020-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will determine the effectiveness of Mitomycin-C use in the glaucoma surgery Ahmed valve implantation. Approximately 100 patients will be enrolled, with half receiving the Mitomycin-C treatment and the other half receiving placebo treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of California, San Francisco
• Collaborators: Asociación para Evitar la Ceguera en México; Bascom Palmer Eye Institute; Hospital Central Militar; Shri Ganesh Vinayak Eye Hospital; University of Colorado, Denver; University of Maryland; University of Maryland, College Park; University of North Carolina; Zhongshan Ophthalmic Center, Sun Yat-sen University; Zhongshan Ophthalmic Center, Sun Yet-san University
• Treatments: Mitomycin; Mitomycins; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

• Inadequately controlled glaucoma on maximum tolerated medical therapy with intraocular pressure (IOP) greater than or equal to 18 mm Hg.

• Ahmed Glaucoma Valve (AGV) implantation as the planned surgical procedure.

• For patients in whom 2 eyes are eligible for enrollment, only the first eligible eye to be implanted is enrolled.

Exclusion Criteria:

• Unwilling or unable to give consent, unwilling to accept randomization, or unable to return for scheduled protocol visits.

• Pregnant or nursing women.

• Previous cyclodestruction or glaucoma drainage device (GDD) surgery.

• Patients with nanophthalmos.

• Patients with Sturge-Weber syndrome or other conditions associated with elevated episcleral venous pressure.

• No light perception vision.

• VA <20/200 in non-study eye.

• Need for glaucoma surgery combined with other ocular procedures (i.e. cataract extraction, penetrating keratoplasty, or retinal surgery) or anticipated need for additional ocular surgery.

• Previous scleral buckling procedure or silicone oil present.

• Uveitic glaucoma.