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Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters (PFC)

Primary Purpose

Neovascular

Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
laser photocoagulation
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 focused on measuring Diabetic retinopathy, Diabetic macular edema, Panretinal photocoagulation

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • untreated Proliferative diabetic retinopathy

Exclusion Criteria:

  • Previous photocoagulation

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    photocoagulation

    Arm Description

    Laser photocoagulation

    Outcomes

    Primary Outcome Measures

    Stabilization of proliferative diabetic retinopathy

    Secondary Outcome Measures

    Full Information

    First Posted
    November 26, 2009
    Last Updated
    December 1, 2009
    Sponsor
    Asociación para Evitar la Ceguera en México
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01023698
    Brief Title
    Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
    Acronym
    PFC
    Official Title
    Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2009
    Overall Recruitment Status
    Unknown status
    Study Start Date
    April 2009 (undefined)
    Primary Completion Date
    April 2010 (Anticipated)
    Study Completion Date
    April 2010 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Asociación para Evitar la Ceguera en México

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Is it possible to do a panretinal photocoagulation for proliferative diabetic retinopathy in a single session using low fluence parameters?

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Neovascular
    Keywords
    Diabetic retinopathy, Diabetic macular edema, Panretinal photocoagulation

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    photocoagulation
    Arm Type
    Experimental
    Arm Description
    Laser photocoagulation
    Intervention Type
    Procedure
    Intervention Name(s)
    laser photocoagulation
    Intervention Description
    Laser photocoagulation
    Primary Outcome Measure Information:
    Title
    Stabilization of proliferative diabetic retinopathy
    Time Frame
    2010

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: untreated Proliferative diabetic retinopathy Exclusion Criteria: Previous photocoagulation
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Maria A Martinez-Castellanos, MD
    Organizational Affiliation
    Asociacion para Evitar la Ceguera en México
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Panretinal Photocoagulation for Proliferative Diabetic Retinopathy in a Single Session Using Low Fluence Parameters

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