Clinical trial NCT02805257: Ahmed Glaucoma Valve Surgery With Mitomycin-C
Official title: Ahmed Glaucoma Valve Surgery With Mitomycin-C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Glaucoma
Primary Open Angle Glaucoma
Secondary Glaucoma
Neovascular Glaucoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: Bascom Palmer Eye Institute
name: University of North Carolina
name: University of Colorado, Denver
name: University of Maryland
name: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Asociación para Evitar la Ceguera en México
name: Hospital Central Militar
name: Shri Ganesh Vinayak Eye Hospital
First posted: 2016-06-17
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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.

Primary outcomes:
measure: Intraocular Pressure After Surgery
timeFrame: 1 year
Secondary outcomes:
measure: Intraocular Pressure After Surgery
timeFrame: 6 months
measure: Number of Medications Postoperatively
timeFrame: 6 months
measure: Visual Acuity
timeFrame: 6 months
measure: Number of Medications Postoperatively
timeFrame: 1 year
measure: Number of Participants With Intraoperative Complications
timeFrame: Day of Surgery
measure: Visual Acuity
timeFrame: 1 year
measure: Number of Participants With Postoperative Complications
timeFrame: 1 Year
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
city: Raipur
country: India
facility: Shri Ganesh Vinayak Eye Hospital
state: Chhattisgarh
city: Mexico City
country: Mexico
facility: Asociación para Evitar la Ceguera en México (APEC)
Study officials:
affiliation: University of California, San Francisco
name: Ying Han, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: