Glaucoma
Conditions
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.
Interventions
DEVICEAurolab glaucoma drainage device
Patients undergoing surgery will receive an implant
PROCEDURETrabeculectomy with mitomycin-c
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.
Sponsors
International Glaucoma Association
HCA International Foundation
Tema Christian Eye Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
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 * 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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| 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 |
| 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 |
Other
| Measure | Time frame |
|---|---|
| Patient satisfaction with communications by text message | 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years |
Countries
Ghana
Contacts
Primary ContactAlexander Spratt, MBBCh FRCOphth
Outcome results
None listed