Status:
UNKNOWN
The Asia Primary Tube Versus Trab (TVT) Study
Lead Sponsor:
Singapore Eye Research Institute
Collaborating Sponsors:
National Medical Research Council (NMRC), Singapore
Conditions:
Glaucoma
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
Detailed Description
The objective of the Asia Primary Tube versus Trab (TVT) study is to compare the efficacy and safety of placement of an Ahmed Glaucoma Implant (AGI) (New World Medical Inc., Rancho Cucamonga, CA, USA)...
Eligibility Criteria
Inclusion
- Open angle glaucoma including primary open angle glaucoma, pseudoexfoliative or pigmentary glaucoma.
- IOP \> 18 mm Hg on 2 or more medications on at least 2 visits
- Informed consent given and consent form signed.
Exclusion
- 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 (keratorefractive surgery and cyclodestructive procedure), except for laser trabeculoplasty procedures (Argon Laser and Selective Laser Trabeculoplasty)
- 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
- Severe posterior blepharitis
- Unwilling to discontinue contact lens use after surgery
- Glaucoma secondary to penetrating keratoplasty, trauma, steroids, 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
- Advanced glaucoma with MD \<-20dB
Key Trial Info
Start Date :
September 28 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 30 2020
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT03274024
Start Date
September 28 2016
End Date
October 30 2020
Last Update
September 6 2017
Active Locations (1)
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1
Singapore Eye Research Institute
Singapore, Singapore, 168751