Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
298 participants
INTERVENTIONAL
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Aurolab glaucoma drainage device
Aurolab glaucoma drainage device
Patients undergoing surgery will receive an implant
Trabeculectomy with mitomycin-c
Trabeculectomy 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.
Interventions
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Aurolab glaucoma drainage device
Patients undergoing surgery will receive an implant
Trabeculectomy 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
85 Years
ALL
No
Sponsors
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International Glaucoma Association
UNKNOWN
HCA International Foundation
UNKNOWN
Tema Christian Eye Center
OTHER
Responsible Party
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Alex Spratt
Principal Investigator
Principal Investigators
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Alexander Spratt, MBBCh FRCOphth
Role: PRINCIPAL_INVESTIGATOR
Tema Christian Eye Center
Keith Barton, MBBCh MD FRCP FRCOphth
Role: STUDY_CHAIR
Moorfields Eye Hospital NHS Foundation Trust
Donald L Budenz, MD MPH
Role: STUDY_CHAIR
University of North Carolina, Chapel Hill
Locations
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Tema Christian Eye Center
Tema, , Ghana
Countries
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Central Contacts
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Related Links
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Related Info
Other Identifiers
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TCEC 044/13-14
Identifier Type: -
Identifier Source: org_study_id
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