Ahmed Glaucoma Valve Surgery With Mitomycin-C

Phase 2

Completed

Conditions: Secondary Glaucoma
Glaucoma
Primary Open Angle Glaucoma
Neovascular Glaucoma

Interventions: Drug: Mitomycin-C
Other: Balanced Salt Solution
Procedure: Ahmed Glaucoma Valve Implant

Registration Number: NCT02805257

Lead Sponsor: University of California, San Francisco

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 119

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mitomycin-C	Mitomycin-C	0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Mitomycin-C	Ahmed Glaucoma Valve Implant	0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.
Balanced Salt Solution (BSS)	Balanced Salt Solution	0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.
Balanced Salt Solution (BSS)	Ahmed Glaucoma Valve Implant	0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.

Primary Outcome Measures

Name	Time	Method
Intraocular Pressure After Surgery	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 Outcome Measures

Name	Time	Method
Number of Participants With Intraoperative Complications	Day of Surgery	Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed.
Number of Participants With Postoperative Complications	1 Year	Postoperative complications are characterized as problems that happened after surgery but which were not intended. All complications up to the one-year after surgery visit observed were listed and analyzed.
Visual Acuity	1 year	The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the one-year after surgery visit. The ETDRS Letter Score is calculated by the number of letters accurately identified at a certain distance, with the range of score being 0-100. An ETDRS letter score of 85 is considered normal vision (equivalent to visual acuity of 20/20), letter scores from 70-84 and 86-100 are considered minimal vision loss and near-normal vision, letter scores from 40-60 are considered moderate visual impairment, and letter scores 0-40 are considered severe visual impairment to total blindness.
Intraocular Pressure After Surgery	6 months	Goldmann applanation tonometry was used to measure intraocular pressure (IOP) at their six-month 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 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.
Number of Medications Postoperatively	1 year	Counted the number of glaucoma drops at one-year after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure.

Trial Locations

Locations (4): Zhongshan Ophthalmic Center
🇨🇳
Guangzhou, Guangdong, China
Shri Ganesh Vinayak Eye Hospital
🇮🇳
Raipur, Chhattisgarh, India
University of California, San Francisco
🇺🇸
San Francisco, California, United States
Asociación para Evitar la Ceguera en México (APEC)
🇲🇽
Mexico City, Mexico