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

NCT ID: NCT02260219

Last Updated: 2024-05-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Neovascular Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP

M4

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type PROCEDURE

Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asociación para Evitar la Ceguera en México

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Felix Gil-Carrasco, MD

Role: STUDY_DIRECTOR

52 55 10841400

Other Identifiers

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GL-12-01

Identifier Type: -

Identifier Source: org_study_id

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