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The Ghana Primary Tube Versus Trabeculectomy Study (GPTVT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02088528
Recruitment Status : Recruiting
First Posted : March 17, 2014
Last Update Posted : March 17, 2014
Sponsor:
Collaborators:
International Glaucoma Association
HCA International Foundation
Information provided by (Responsible Party):
Alex Spratt, Tema Christian Eye Center

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.


Condition or disease Intervention/treatment Phase
Glaucoma Device: Aurolab glaucoma drainage device Procedure: Trabeculectomy with mitomycin-c Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 298 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Ghana Primary Tube Versus Trabeculectomy Study
Study Start Date : March 2014
Estimated Primary Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Active Comparator: Aurolab glaucoma drainage device Device: Aurolab glaucoma drainage device
Patients undergoing surgery will receive an implant
Other Name: 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]
  2. 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 ]
  3. Visual field [ Time Frame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]
  4. 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 ]
  5. 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 ]
  6. Quality of life [ Time Frame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088528


Contacts
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Contact: Alexander Spratt, MBBCh FRCOphth +233549446981 mail@gptvt.com

Locations
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Ghana
Tema Christian Eye Center Recruiting
Tema, Ghana
Principal Investigator: Alexander Spratt, MBBCh FRCOphth         
Sponsors and Collaborators
Tema Christian Eye Center
International Glaucoma Association
HCA International Foundation
Investigators
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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
Additional Information:
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Responsible Party: Alex Spratt, Principal Investigator, Tema Christian Eye Center
ClinicalTrials.gov Identifier: NCT02088528    
Other Study ID Numbers: TCEC 044/13-14
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014
Additional relevant MeSH terms:
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Glaucoma
Ocular Hypertension
Eye Diseases
Mitomycins
Mitomycin
Antibiotics, Antineoplastic
Antineoplastic Agents
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors