Ahmed Glaucoma Valve Surgery With Mitomycin-C
Status: | Active, not recruiting |
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Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 18 - 85 |
Updated: | 4/29/2018 |
Start Date: | June 2016 |
End Date: | December 2018 |
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.
valve implantation. Approximately 100 patients will be enrolled, with half receiving the
Mitomycin-C treatment and the other half receiving placebo treatment.
Glaucoma is a leading cause irreversible blindness worldwide. Glaucoma valve surgeries such
as Ahmed valve implantation, which are conventional surgeries performed to control
intraocular pressure in eyes, are sometimes associated with complications due to fibrosis.
Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will
evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
as Ahmed valve implantation, which are conventional surgeries performed to control
intraocular pressure in eyes, are sometimes associated with complications due to fibrosis.
Mitomycin-C is a commonly used antifibrotic agent used in glaucoma surgeries. This study will
evaluate the effectiveness of Mitomycin-C injections intraoperatively and postoperatively.
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.
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