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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02260219
Other study ID # GL-12-01
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date January 2012
Est. completion date February 2013

Study information

Verified date May 2024
Source Asociación para Evitar la Ceguera en México
Contact n/a
Is FDA regulated No
Health authority
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 Terminated
Enrollment 42
Est. completion date February 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender All
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


Related Conditions & MeSH terms


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
Secondary Intraocular pressure 1 year
See also
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