Ahmed Glaucoma Valve Surgery With Mitomycin-C

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2020-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Glaucoma Primary Open Angle Glaucoma Secondary Glaucoma Neovascular Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Mitomycin-C

0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively.

Group Type EXPERIMENTAL

Mitomycin-C

Intervention Type DRUG

Intraoperative and postoperative injections of mitomycin-c/Mitosol

Ahmed Glaucoma Valve Implant

Intervention Type PROCEDURE

Implantation of Ahmed Valve in study eye

Balanced Salt Solution (BSS)

0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively.

Group Type PLACEBO_COMPARATOR

Balanced Salt Solution

Intervention Type OTHER

Intraoperative and postoperative injections of BSS

Ahmed Glaucoma Valve Implant

Intervention Type PROCEDURE

Implantation of Ahmed Valve in study eye

Interventions

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Mitomycin-C

Intraoperative and postoperative injections of mitomycin-c/Mitosol

Intervention Type DRUG

Balanced Salt Solution

Intraoperative and postoperative injections of BSS

Intervention Type OTHER

Ahmed Glaucoma Valve Implant

Implantation of Ahmed Valve in study eye

Intervention Type PROCEDURE

Other Intervention Names

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Mitosol BSS

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes