Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma

Not Applicable

Terminated

• Conditions: Neovascular Glaucoma
• Interventions: Procedure: Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2

• 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

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-02
• Study Completion: 2013-02
• Study First Submitted: 2014-07-17
• Study First Submitted QC: 2014-10-06
• Study First Posted: 2014-10-09
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-29
• Last Update Posted: 2024-05-30

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

Arm && Interventions

Group	Intervention	Description
M4	Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2	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
S2	Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2	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

Primary Outcome Measures

Name	Time	Method
Number of participants with adverse effects	1 year

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	1 year