Ahmed Glaucoma Valve Surgery With Mitomycin-C
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 119
- Locations
- 4
- Primary Endpoint
- Intraocular Pressure After Surgery
Study Overview
Brief 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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Mitomycin-C
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Intervention: Mitomycin-C (Drug)
Mitomycin-C
0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Intervention: Ahmed Glaucoma Valve Implant (Procedure)
Balanced Salt Solution (BSS)
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Intervention: Balanced Salt Solution (Other)
Balanced Salt Solution (BSS)
0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Intervention: Ahmed Glaucoma Valve Implant (Procedure)
Outcomes
Primary Outcomes
Intraocular Pressure After Surgery
Time Frame: 1 year
Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their one-year after surgery visit, however, for patients with irregular corneal astigmatism, corneal scarring, or corneal edema, which affect accurate measurement, pneumatonometer or Tonopen (Reichert Technologies, Depew, NY) was used. Two consecutive measurements were taken for the study eye. If the 2 measurements differ by 1 mm Hg or less, the IOP for the study eye was the average of the 2 readings. If the 2 measurements differ by 2 mm Hg or more, a third measurement was taken, and the IOP for the study eye was the median of the 3 readings. Efforts were made to schedule follow-up visits at similar time of the day to minimize the effect of diurnal IOP fluctuation. The average IOP and its standard deviation for each arm were calculated based on the individual IOP result obtained using the method described above.
Secondary Outcomes
- Number of Participants With Intraoperative Complications(Day of Surgery)
- Number of Participants With Postoperative Complications(1 Year)
- Visual Acuity(1 year)
- Intraocular Pressure After Surgery(6 months)
- Number of Medications Postoperatively(1 year)