Overview

This trial is active, not recruiting.

Condition neovascular glaucoma
Treatment surgical implant of ahmed glaucoma drainage device, model m4 and s2
Sponsor Asociación para Evitar la Ceguera en México
Start date January 2012
End date February 2013
Trial size 42 participants
Trial identifier NCT02260219, GL-12-01

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Surgically Implant an Ahmed Glaucoma Drainage Device Model S2 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
surgical implant of ahmed glaucoma drainage device, model m4 and s2
Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP
(Active Comparator)
Surgically Implant an Ahmed Glaucoma Drainage Device Model M4 in Neovascular Glaucoma Patients and evaluate the IOP evolution, complications and need for medication to control IOP
surgical implant of ahmed glaucoma drainage device, model m4 and s2
Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP

Primary Outcomes

Measure
Number of participants with adverse effects
time frame: 1 year

Secondary Outcomes

Measure
Intraocular pressure
time frame: 1 year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2014.
Information provided to ClinicalTrials.gov by Asociación para Evitar la Ceguera en México.