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

Primary Purpose

Neovascular Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
Sponsored by
Asociación para Evitar la Ceguera en México
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neovascular Glaucoma focused on measuring Ahmed implant, Neovascular Glaucoma, Intraocular pressure

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    S2

    M4

    Arm Description

    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

    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

    Outcomes

    Primary Outcome Measures

    Number of participants with adverse effects

    Secondary Outcome Measures

    Intraocular pressure

    Full Information

    First Posted
    July 17, 2014
    Last Updated
    October 6, 2014
    Sponsor
    Asociación para Evitar la Ceguera en México
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02260219
    Brief Title
    Comparative Study, Safety and Efficacy, Ahmed Glaucoma Drainage Device, Model M4 Model S2 in Neovascular Glaucoma
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2014
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2012 (undefined)
    Primary Completion Date
    February 2013 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Asociación para Evitar la Ceguera en México

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neovascular Glaucoma
    Keywords
    Ahmed implant, Neovascular Glaucoma, Intraocular pressure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    42 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    S2
    Arm Type
    Active Comparator
    Arm Description
    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
    Arm Title
    M4
    Arm Type
    Active Comparator
    Arm Description
    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
    Intervention Type
    Procedure
    Intervention Name(s)
    Surgical Implant of Ahmed Glaucoma Drainage Device, model M4 and S2
    Intervention Description
    Surgically Implant an Ahmed Glaucoma Drainage Device Models S2 and M4, evaluare IOP evolution, complications and need for medication to control IOP
    Primary Outcome Measure Information:
    Title
    Number of participants with adverse effects
    Time Frame
    1 year
    Secondary Outcome Measure Information:
    Title
    Intraocular pressure
    Time Frame
    1 year

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Felix Gil-Carrasco, MD
    Organizational Affiliation
    52 55 10841400
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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