The Ghana Primary Tube Versus Trabeculectomy Study

Glaucoma Clinical Trial

— GPTVT  

Official title:

The Ghana Primary Tube Versus Trabeculectomy Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02088528
• Other study ID #: TCEC 044/13-14
• Status: Recruiting
• Phase: N/A
• First received: March 11, 2014
• Last updated: March 14, 2014
• Start date: March 2014

Study information

• Verified date: March 2014
• Source: Tema Christian Eye Center
• Contact: Alexander Spratt, MBBCh FRCOphth
• Phone: +233549446981
• Email: mail[@]gptvt.com
• Is FDA regulated: No
• Health authority: Ghana: The Food and Drugs Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 298
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma

Intervention

Device:
• Aurolab glaucoma drainage device
Patients undergoing surgery will receive an implant

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.

Locations

Country	Name	City	State
Ghana	Tema Christian Eye Center	Tema

Sponsors (3)

Lead Sponsor	Collaborator
Tema Christian Eye Center	HCA International Foundation, International Glaucoma Association

Country where clinical trial is conducted

Ghana, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient satisfaction with communications by text message		1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	No
Primary	Change in intraocular pressure		3 months, 6 months, 1 year, 18 months, 2 years, 2½ years, 3 years, 3½ years, 4 years, 4½ years, 5 years	No
Secondary	Complication rates		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	Yes
Secondary	Visual acuity		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	Yes
Secondary	Visual field		6 months, 1 year, 2 years, 3 years, 4 years, 5 years	Yes
Secondary	Reoperation for glaucoma		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	No
Secondary	Supplemental medical therapy		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	No
Secondary	Quality of life		1 week, 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, 5 years	No

External Links

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