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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

Page last updated: August 20, 2015

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