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Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion

Primary Purpose

Central Retinal Vein Occlusion

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Retinal endo vascular surgery
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring retinal vein occlusion, rTPA

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • crvo less than 6 month
  • Visual Acuity less than 6/21
  • No prior eye surgery except cataract.

Exclusion Criteria:

  • Retinal/iris neovascularization

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Visual acuity
    Amount of macular edema.

    Secondary Outcome Measures

    Full Information

    First Posted
    October 3, 2006
    Last Updated
    October 3, 2006
    Sponsor
    Hadassah Medical Organization
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00383773
    Brief Title
    Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2006
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2006 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    October 2007 (Anticipated)

    3. Sponsor/Collaborators

    Name of the Sponsor
    Hadassah Medical Organization

    4. Oversight

    5. Study Description

    Brief Summary
    Patients with Central Retinal Vein Occlusion will undergo vitrectomy, a small needle of about 71 micron will enter a branch retinal vein and TPA will be injected into the obstracted vein.
    Detailed Description
    Patients with Central Retinal Vein Occlusion less than 6 month duration and reduction of vision to 6/21 will go OCT and FANG examinations. Patient will be operated vitrectomy, and a branch retinal vein will be punctured by small needle and rTPA 200mcg/ml will be injected to the vein.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Central Retinal Vein Occlusion
    Keywords
    retinal vein occlusion, rTPA

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    10 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Retinal endo vascular surgery
    Primary Outcome Measure Information:
    Title
    Visual acuity
    Title
    Amount of macular edema.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: crvo less than 6 month Visual Acuity less than 6/21 No prior eye surgery except cataract. Exclusion Criteria: Retinal/iris neovascularization
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Michael Halpert, MD.
    Phone
    00972507874385
    Email
    halpert@cc.huji.ac.il
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hadas Lemberg, PhD
    Phone
    0097226777572
    Email
    Ihadas@hadassah.org.il
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Michael halpert
    Organizational Affiliation
    Hadassah Medical Organization
    Official's Role
    Study Chair

    12. IPD Sharing Statement

    Learn more about this trial

    Retinal Endo Vascular Surgery for Central Retinal Vein Occlusion

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