An interventional study of Aurolab glaucoma drainage device and Trabeculectomy with mitomycin-c in Glaucoma, sponsored by Tema Christian Eye Center. Status unknown at 1 site in Ghana. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2014-03-17.
Sponsored by Tema Christian Eye Center · Not applicable, Interventional, and Treatment
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.
1,844 studies on the registry are indexed under Glaucoma; 233 are open to participants now.
This study's planned enrollment of 298 is above the median of 65 across 1,296 interventional studies indexed under Glaucoma.
Browse Glaucoma studies →Tema Christian Eye Center is the lead sponsor of 2 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Device: Aurolab glaucoma drainage device
Procedure: Trabeculectomy with mitomycin-c
Patients undergoing surgery will receive an implant
Also known as: AADI
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.
Change 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
Patient satisfaction with communications by text message
Time frame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
This study is status unknown, as verified in Mar 2014. You cannot join it, but the record below documents what was studied.
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Tema Christian Eye Center