Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma
Not Applicable
Terminated
- Conditions
- Neovascular Glaucoma
- Registration Number
- NCT02260219
- Lead Sponsor
- Asociación para Evitar la Ceguera en México
- Brief Summary
Objective: Prospectively evaluate the safety and efficacy of the Ahmed Glaucoma Drainage Device, model M4 compared with the model S2.
Method: Mexican patients with Neovascular Glaucoma will be randomly included for each group (M4 and S2). They will be operated using conventional techniques and creating a sub-episcleral tunnel to place the valve's tube in the anterior chamber. They will be monitoring for one year and the results will be evaluated with respect to a postoperative reduction in pressure, changes in visual acuity, the need for drugs and complications, in addition to the demographic characteristics of each group.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 42
Inclusion Criteria
- Patients with diagnosis of Neovascular glaucoma
- High IOP despite topical treatment
Exclusion Criteria
- Pregnant women
- Mental disorders
- Previous glaucoma surgery
- Patients older than 18 years
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Number of participants with adverse effects 1 year
- Secondary Outcome Measures
Name Time Method Intraocular pressure 1 year