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The Ghana Primary Tube Versus Trabeculectomy Study (GPTVT)

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Ghana
Study Type
Interventional
Intervention
Aurolab glaucoma drainage device
Trabeculectomy with mitomycin-c
Sponsored by
Tema Christian Eye Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tema Christian Eye CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Aurolab glaucoma drainage device

Trabeculectomy with mitomycin-c

Arm Description

Outcomes

Primary Outcome Measures

Change in intraocular pressure

Secondary Outcome Measures

Complication rates
Visual acuity
Visual field
Reoperation for glaucoma
Supplemental medical therapy
Quality of life

Full Information

First Posted
March 11, 2014
Last Updated
March 14, 2014
Sponsor
Tema Christian Eye Center
Collaborators
International Glaucoma Association, HCA International Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02088528
Brief Title
The Ghana Primary Tube Versus Trabeculectomy Study
Acronym
GPTVT
Official Title
The Ghana Primary Tube Versus Trabeculectomy Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
March 2021 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tema Christian Eye Center
Collaborators
International Glaucoma Association, HCA International Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
298 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Aurolab glaucoma drainage device
Arm Type
Active Comparator
Arm Title
Trabeculectomy with mitomycin-c
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
Aurolab glaucoma drainage device
Other Intervention Name(s)
AADI
Intervention Description
Patients undergoing surgery will receive an implant
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy with mitomycin-c
Intervention Description
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 Measure Information:
Title
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 Measure Information:
Title
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
Title
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
Title
Visual field
Time Frame
6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Title
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
Title
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
Title
Quality of life
Time Frame
1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Other Pre-specified Outcome Measures:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alexander Spratt, MBBCh FRCOphth
Phone
+233549446981
Email
mail@gptvt.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander Spratt, MBBCh FRCOphth
Organizational Affiliation
Tema Christian Eye Center
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Keith Barton, MBBCh MD FRCP FRCOphth
Organizational Affiliation
Moorfields Eye Hospital NHS Foundation Trust
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Donald L Budenz, MD MPH
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Study Chair
Facility Information:
Facility Name
Tema Christian Eye Center
City
Tema
Country
Ghana
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexander Spratt, MBBCh FRCOphth

12. IPD Sharing Statement

Links:
URL
http://www.gptvt.com
Description
Related Info

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The Ghana Primary Tube Versus Trabeculectomy Study

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