The Ghana Primary Tube Versus Trabeculectomy Study (GPTVT)

March 14, 2014 updated by: Alex Spratt, Tema Christian Eye Center

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

298

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Ghana
      • Tema, Ghana
        • Recruiting
        • Tema Christian Eye Center
        • Principal Investigator:
          • Alexander Spratt, MBBCh FRCOphth

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Aurolab glaucoma drainage device
Device: Aurolab glaucoma drainage device
Patients undergoing surgery will receive an implant
Other Names:
  • AADI
Active Comparator: Trabeculectomy with mitomycin-c
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
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
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
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
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
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
1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Other Outcome Measures

Outcome Measure
Time Frame
Patient satisfaction with communications by text message
Time Frame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tema Christian Eye Center

Collaborators

International Glaucoma Association
HCA International Foundation

Investigators

  • Principal Investigator: Alexander Spratt, MBBCh FRCOphth, Tema Christian Eye Center
  • Study Chair: Keith Barton, MBBCh MD FRCP FRCOphth, Moorfields Eye Hospital NHS Foundation Trust
  • Study Chair: Donald L Budenz, MD MPH, University of North Carolina, Chapel Hill

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Anticipated)

March 1, 2021

Study Registration Dates

First Submitted

March 11, 2014

First Submitted That Met QC Criteria

March 14, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Estimate)

March 17, 2014

Last Update Submitted That Met QC Criteria

March 14, 2014

Last Verified

March 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TCEC 044/13-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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