The Ghana Primary Tube Versus Trabeculectomy Study (GPTVT)

Tema Christian Eye Center

Status: Unknown

Conditions: Glaucoma

Treatments: Device: Aurolab glaucoma drainage device; Procedure: Trabeculectomy with mitomycin-c

Study type: Interventional

Funder types: Other

Identifiers

NCT02088528

TCEC 044/13-14

Details and patient eligibility

About

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.

Enrollment: 298 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

298 participants in 2 patient groups

Aurolab glaucoma drainage device

Active Comparator group

Treatment:

Device: Aurolab glaucoma drainage device

Trabeculectomy with mitomycin-c

Active Comparator group

Treatment:

Procedure: Trabeculectomy with mitomycin-c