Clinical trial NCT02088528: The Ghana Primary Tube Versus Trabeculectomy Study
Official title: The Ghana Primary Tube Versus Trabeculectomy Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Glaucoma
Lead sponsor: Tema Christian Eye Center
Sponsor class: OTHER
Collaborators: name: International Glaucoma Association
name: HCA International Foundation
First posted: 2014-03-17
Enrollment: 298
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in intraocular pressure
timeFrame: 3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years
Secondary outcomes:
measure: Complication rates
timeFrame: 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
measure: Visual acuity
timeFrame: 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
measure: Visual field
timeFrame: 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
measure: Reoperation for glaucoma
timeFrame: 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
measure: Supplemental medical therapy
timeFrame: 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
measure: Quality of life
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Other outcomes:
measure: Patient satisfaction with communications by text message
timeFrame: 1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years
Locations:
city: Tema
country: Ghana
facility: Tema Christian Eye Center
Study officials:
affiliation: Tema Christian Eye Center
name: Alexander Spratt, MBBCh FRCOphth
role: PRINCIPAL_INVESTIGATOR
affiliation: Moorfields Eye Hospital NHS Foundation Trust
name: Keith Barton, MBBCh MD FRCP FRCOphth
role: STUDY_CHAIR
affiliation: University of North Carolina, Chapel Hill
name: Donald L Budenz, MD MPH
role: STUDY_CHAIR
References: