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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02088528 |
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Date of registration:
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11/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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The Ghana Primary Tube Versus Trabeculectomy Study
GPTVT |
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Scientific title:
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The Ghana Primary Tube Versus Trabeculectomy Study |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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298 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02088528 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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N/A
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Countries of recruitment
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Ghana
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Contacts
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Name:
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Alexander Spratt, MBBCh FRCOphth |
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Address:
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Telephone:
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+233549446981 |
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Email:
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mail@gptvt.com |
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Affiliation:
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Name:
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Alexander Spratt, MBBCh FRCOphth |
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Address:
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Telephone:
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Email:
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Affiliation:
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Tema Christian Eye Center |
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Name:
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Keith Barton, MBBCh MD FRCP FRCOphth |
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Address:
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Telephone:
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Email:
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Affiliation:
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Moorfields Eye Hospital NHS Foundation Trust |
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Name:
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Donald L Budenz, MD MPH |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of North Carolina, Chapel Hill |
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Key inclusion & exclusion criteria
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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
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Glaucoma
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Intervention(s)
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Procedure: Trabeculectomy with mitomycin-c
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Device: Aurolab glaucoma drainage device
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Primary Outcome(s)
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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]
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Secondary Outcome(s)
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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]
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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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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]
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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]
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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]
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Visual field
[Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years]
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Secondary ID(s)
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TCEC 044/13-14
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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