The Ghana Primary Tube Versus Trabeculectomy Study

  • STATUS
    Recruiting
  • participants needed
    298
  • sponsor
    Tema Christian Eye Center
Updated on 8 November 2020
drainage
medical therapy
mitomycin
intraocular pressure
trabeculectomy
pigmentary glaucoma
primary open angle glaucoma
treatment of glaucoma

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.

Details
Condition Glaucoma
Treatment Aurolab glaucoma drainage device, Trabeculectomy with mitomycin-c
Clinical Study IdentifierNCT02088528
SponsorTema Christian Eye Center
Last Modified on8 November 2020

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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