GlaucomaGPTVTNCT02088528
The Ghana Primary Tube Versus Trabeculectomy Study
A study testing Aurolab glaucoma drainage device and Trabeculectomy with mitomycin-c in people with Glaucoma, run by Tema Christian Eye Center at 1 site in Ghana.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Glaucoma
- What is being tested?
- Aurolab glaucoma drainage device and Trabeculectomy with mitomycin-c
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 298 participants
- Where
- 1 siteGhana
- Study dates
- Mar 2014to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Ghana1 site, 1 recruiting
- Recruiting
Tema Christian Eye Center
Tema
Alexander Spratt, MBBCh FRCOphth
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Aurolab glaucoma drainage device, Trabeculectomy with mitomycin-c
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aurolab glaucoma drainage deviceDevice
Also called AADI
Patients undergoing surgery will receive an implant
Trabeculectomy with mitomycin-cProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Aurolab glaucoma drainage device | Active comparator | Not described Receives: Device: Aurolab glaucoma drainage device |
| Trabeculectomy with mitomycin-c | Active comparator | Not described Receives: Procedure: Trabeculectomy with mitomycin-c |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intraocular pressure
Measured: 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years
Secondary outcomes (6)
Complication rates
Measured: 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
Measured: 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
Measured: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Reoperation for glaucoma
Measured: 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
Measured: 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
Measured: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study startMar 2014
- Primary completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 298 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tema Christian Eye Center
- Sponsor type
- University, hospital or other
- Collaborators
- International Glaucoma Association, HCA International Foundation
- Responsible party
- Principal investigator, Alex Spratt, Tema Christian Eye Center
- Investigators
- Alexander Spratt, MBBCh FRCOphth, Principal investigator, Tema Christian Eye CenterKeith Barton, MBBCh MD FRCP FRCOphth, Study chair, Moorfields Eye Hospital NHS Foundation TrustDonald L Budenz, MD MPH, Study chair, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088528
- Sponsor's protocol ID
- TCEC 044/13-14
- Acronym
- GPTVT
- Status last verified
- Mar 2014
- First submitted
- 11 Mar 2014
- Last updated
- 17 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Ghana Primary Tube Versus Trabeculectomy Study
- ClinicalTrials.gov ID
- NCT02088528
- Acronym / sponsor ID
- GPTVT / TCEC 044/13-14
- Conditions
- Glaucoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 298 participants (estimated)
- Lead sponsor
- Tema Christian Eye CenterUniversity, hospital or other
- Collaborators
- International Glaucoma Association, HCA International Foundation
- Study start
- Mar 2014
- Primary completion
- Mar 2021 (estimated)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Aurolab glaucoma drainage device | Active comparator | Device: Aurolab glaucoma drainage device |
| Trabeculectomy with mitomycin-c | Active comparator | Procedure: Trabeculectomy with mitomycin-c |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aurolab glaucoma drainage deviceAlso: AADIPatients undergoing surgery will receive an implant | Device | Aurolab glaucoma drainage device |
| Trabeculectomy with mitomycin-cTrabeculectomy 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. | Procedure or surgery | Trabeculectomy with mitomycin-c |
Primary outcome
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
6 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2014.
- Related InfoLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Spratt, MBBCh FRCOphth principal investigator
Tema Christian Eye Center
Keith Barton, MBBCh MD FRCP FRCOphth study chair
Moorfields Eye Hospital NHS Foundation Trust
Donald L Budenz, MD MPH study chair
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aurolab glaucoma drainage device and Trabeculectomy with mitomycin-c in people with Glaucoma, run by Tema Christian Eye Center at 1 site in Ghana.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ghana. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexander Spratt, MBBCh FRCOphth (+233549446981, mail@gptvt.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2014.