The Asia Primary Tube Versus Trab (TVT) Study
NCT03274024 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2017-09-06
Summary
Comparison of Ahmed Glaucoma Implant (AGI) against trabeculectomy with mitomycin C in patients with uncontrolled open angle glaucoma
Conditions
Interventions
- DEVICE
-
Ahmed Glaucoma Implant
Conjunctival Flap Scleral Exposure Insertion of Episcleral Plate Priming of the tube prior to AC entrance Insertion of Tube into the Anterior Chamber Suturing tube Coverage of tube
- PROCEDURE
-
Trabeculectomy with Mitomycin C
Conjunctival Flap Mitomycin C Application Scleral Flap Paracentesis Excision of Limbal Tissue Peripheral Iridectomy Scleral Flap Closure Conjunctival Flap Closure
Sponsors & Collaborators
-
National Medical Research Council (NMRC), Singapore
collaborator OTHER_GOV -
Singapore Eye Research Institute
lead OTHER
Principal Investigators
-
Ching Lin Ho · Singapore National Eye Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-09-28
- Primary Completion
- 2020-10-30
- Completion
- 2020-10-30
- FDA Device
- Yes
Countries
- Singapore
Study Locations
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