NCT02088528UnknownNot Applicable
The Ghana Primary Tube Versus Trabeculectomy Study
Tema Christian Eye Center1 site in 1 country298 target enrollmentStarted: March 1, 2014Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 298
- Locations
- 1
- Primary Endpoint
- Change in intraocular pressure
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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
Arms & Interventions
Aurolab glaucoma drainage device
Active Comparator
Intervention: Aurolab glaucoma drainage device (Device)
Trabeculectomy with mitomycin-c
Active Comparator
Intervention: Trabeculectomy with mitomycin-c (Procedure)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- 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)
Investigators
Alex Spratt
Principal Investigator
Tema Christian Eye Center
Study Sites (1)
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