Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma
Information source: Asociación para Evitar la Ceguera en México
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neovascular Glaucoma
Intervention: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2 (Procedure)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Asociación para Evitar la Ceguera en México Official(s) and/or principal investigator(s): Felix Gil-Carrasco, MD, Study Director, Affiliation: 52 55 10841400
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.
Clinical Details
Official title: Comparative Study of the Safety and Efficacy of the Ahmed Glaucoma Valve Drainage Device, Model M4 (High Density Porous Polyethylene) and the Model S2 (Polypropylene) in Patients With Neovascular Glaucoma
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of participants with adverse effects
Secondary outcome: Intraocular pressure
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Additional Information
Starting date: January 2012
Last updated: October 6, 2014
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