Ahmed Glaucoma Valve Surgery With Mitomycin-C (NCT02805257) | Clinical Trial Compass
CompletedPhase 2
Ahmed Glaucoma Valve Surgery With Mitomycin-C
United States, China, India119 participantsStarted 2016-06
Plain-language 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.
Who can participate
Age range18 Years ā 85 Years
SexALL
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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.