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

Neovascular Glaucoma Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02260219
• Other study ID #: GL-12-01
• Status: Active, not recruiting
• Phase: N/A
• First received: July 17, 2014
• Last updated: October 6, 2014
• Start date: January 2012

Study information

• Verified date: September 2014
• Source: Asociación para Evitar la Ceguera en México
• Contact: n/a
• Is FDA regulated: No
• Health authority: Mexico: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 42
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Neovascular
• Neovascular Glaucoma

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with adverse effects		1 year	Yes
Secondary	Intraocular pressure		1 year	Yes