The Ghana Primary Tube Versus Trabeculectomy Study

Study Overview
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Brief Summary
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Medical treatment of glaucoma in West Africa is often unsuccessful because of the cost of medications, disease severity and poor compliance. Surgical treatment is likely to be a more practical solution. The purpose of this study is to compare the safety and efficacy of the Aurolab glaucoma drainage device against trabeculectomy with mitomycin-c in a prospective randomised surgical study.

Official Title
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The Ghana Primary Tube Versus Trabeculectomy Study

Conditions
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Glaucoma

Intervention / Treatment
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* Device: Aurolab glaucoma drainage device
* Procedure: Trabeculectomy with mitomycin-c


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 85 years, inclusive Open angle glaucoma. Including primary open angle glaucoma, pseudoexfoliative and pigmentary glaucoma Intraocular pressure 18 - 40 mmHg on maximal tolerated or maximal affordable medical therapy Informed consent given and consent form signed. Exclusion Criteria: Unwilling or unable to give consent, unwilling to accept randomisation, or unable to return for scheduled protocol visits Pregnant or nursing women No light perception vision Previous incisional intraocular surgery, other than uncomplicated clear corneal cataract surgery Previous ocular laser in study eye Iris neovascularisation or proliferative retinopathy Primary angle closure or primary angle closure glaucoma Iridocorneal endothelial syndrome or anterior segment dysgenesis Epithelial or fibrous downgrowth Aphakia Chronic or recurrent uveitis Steroid-induced glaucoma Severe posterior blepharitis Unwilling to discontinue contact lens use after surgery Previous cyclodestructive procedure Glaucoma secondary to penetrating keratoplasty, trauma, retinal disease/surgery or neovascular disease Conjunctival scarring from prior ocular surgery, trauma or cicatrizing disease precluding a superior trabeculectomy Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, penetrating keratoplasty, or retinal surgery) or anticipated need for urgent additional ocular surgery

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aurolab glaucoma drainage device<br> | Device: Aurolab glaucoma drainage device<br>* Patients undergoing surgery will receive an implant<br>* Other names: AADI;|
| Active Comparator: Trabeculectomy with mitomycin-c<br> | Procedure: Trabeculectomy with mitomycin-c<br>* Trabeculectomy surgery augmented by application of mitomycin C (0.4 mg/ml) to the sclera in the region of the trabeculectomy site for a period of exactly 3 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in intraocular pressure |  | 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rates |  | 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years | 
| Visual acuity |  | 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years | 
| Visual field |  | 6 months, 1 year, 2 years, 3 years, 4 years, 5 years | 
| Reoperation for glaucoma |  | 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years | 
| Supplemental medical therapy |  | 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years | 
| Quality of life |  | 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |