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
About this trial
This is an interventional treatment trial for Central Retinal Vein Occlusion focused on measuring retinal vein occlusion, rTPA
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
Sites / Locations
Outcomes
Primary Outcome Measures
Visual acuity
Amount of macular edema.
Secondary Outcome Measures
Full Information
NCT ID
NCT00383773
First Posted
October 3, 2006
Last Updated
October 3, 2006
Sponsor
Hadassah Medical Organization
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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