Ahmed Glaucoma Valve Surgery With Mitomycin-C

Study Overview
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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.

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.

Official Title
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Ahmed Glaucoma Valve Surgery With Mitomycin-C

Conditions
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Glaucoma, Primary Open Angle Glaucoma, Secondary Glaucoma, Neovascular Glaucoma

Intervention / Treatment
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* Drug: Mitomycin-C
* Other: Balanced Salt Solution
* Procedure: Ahmed Glaucoma Valve Implant


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mitomycin-C<br>0.1 ml of Mitomycin-C 0.4mg/ml injection intraoperatively and twice postoperatively. | Drug: Mitomycin-C<br>* Intraoperative and postoperative injections of mitomycin-c/Mitosol<br>* Other names: Mitosol;Procedure: Ahmed Glaucoma Valve Implant<br>* Implantation of Ahmed Valve in study eye<br>|
| Placebo Comparator: Balanced Salt Solution (BSS)<br>0.1ml Balanced Salt Solution injection intraoperatively and twice postoperatively. | Other: Balanced Salt Solution<br>* Intraoperative and postoperative injections of BSS<br>* Other names: BSS;Procedure: Ahmed Glaucoma Valve Implant<br>* Implantation of Ahmed Valve in study eye<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure After Surgery | 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. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure After Surgery | 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. | 6 months | 
| Number of Medications Postoperatively | Counted the number of glaucoma drops at six-month after surgery visit. Glaucoma drops are characterized as topical medication used to help lower intraocular pressure. | 6 months | 
| Visual Acuity | The Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity is tested at the six-month 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. | 6 months | 
| Number of Medications Postoperatively | 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. | 1 year | 
| Number of Participants With Intraoperative Complications | Intraoperative complications are characterized as problems that happened during surgery but which were not intended. All complications during surgery were listed and analyzed. | Day of Surgery | 
| Visual Acuity | 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. | 1 year | 
| Number of Participants With Postoperative Complications | 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. | 1 Year |