Trials / Unknown
UnknownNCT03274024
The Asia Primary Tube Versus Trab (TVT) Study
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- Sponsor
- Singapore Eye Research Institute · Academic / Other
- Sex
- All
- Age
- 18 Years – 85 Years
- Healthy volunteers
- Not accepted
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) against trabeculectomy with mitomycin C in patients with uncontrolled glaucoma, who may or may not have had previous clear corneal cataract surgery with intraocular lens implantation, over 5 years. Outcome discrimination between the two treatment groups will be made using following parameters: 1. Intraocular pressure 2. Need for supplemental medical therapy 3. Incidence of short and long term surgical complications and need for re-operation. 4. Visual function (Visual acuity and Visual field) Hypothesis: Glaucoma drainage implants have better surgical outcomes in terms of IOP lowering efficacy compared to trabeculectomy with mitomycin-C over 5 years in Asian patients with medically uncontrolled glaucoma.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2016-09-28
- Primary completion
- 2020-10-30
- Completion
- 2020-10-30
- First posted
- 2017-09-06
- Last updated
- 2017-09-06
Locations
1 site across 1 country: Singapore
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03274024. Inclusion in this directory is not an endorsement.