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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
298
Patients undergoing surgery will receive an implant
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.
Tema Christian Eye Center
Tema, Ghana
RECRUITINGChange in intraocular pressure
Time frame: 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years
Complication rates
Time frame: 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
Time frame: 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
Time frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Reoperation for glaucoma
Time frame: 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
Time frame: 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
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
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