Back to resultsSubmacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
Primary Purpose
Submacular Hemorrhage, Ruptured Retinal Arterial Macro Aneurysms
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
Vitrectomy for submacular hemorrhage
subretinal injection of tissue-plasminogen activator
Sponsored by
About this trial
This is an interventional treatment trial for Submacular Hemorrhage focused on measuring Submacular hemorrhage, Vitrectomy, tissue- plasminogen activator
Eligibility Criteria
Inclusion Criteria:
- The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms
Exclusion Criteria:
- The eyes with preretinal or intraretinal hemorrhage at the fovea
- The patients with follow-up less than 3 months
Sites / Locations
- Kyorin Eye Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Vitrectomy
Arm Description
Outcomes
Primary Outcome Measures
Displacement of sub macular hemorrhage
Anatomical recovery detected funduscopy and optical coherence tomography
Secondary Outcome Measures
Visual acuity
Visual recovery after surgery
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02120066
Brief Title
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
Study Type
Interventional
2. Study Status
Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyorin University
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Evaluation of surgical outcome of vitrectomy with subretinal injection of recombinant tissue-plasminogen activator for submacular hemorrhage associated with retinal arterial macroanuerysms.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Submacular Hemorrhage, Ruptured Retinal Arterial Macro Aneurysms
Keywords
Submacular hemorrhage, Vitrectomy, tissue- plasminogen activator
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vitrectomy
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
Vitrectomy for submacular hemorrhage
Intervention Type
Drug
Intervention Name(s)
subretinal injection of tissue-plasminogen activator
Primary Outcome Measure Information:
Title
Displacement of sub macular hemorrhage
Description
Anatomical recovery detected funduscopy and optical coherence tomography
Time Frame
one year
Secondary Outcome Measure Information:
Title
Visual acuity
Description
Visual recovery after surgery
Time Frame
one year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
95 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
The patients with sub macular hemorrhage associated with ruptured retinal arterial macro aneurysms
Exclusion Criteria:
The eyes with preretinal or intraretinal hemorrhage at the fovea
The patients with follow-up less than 3 months
Facility Information:
Facility Name
Kyorin Eye Center
City
Mitaka
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
12. IPD Sharing Statement
Links:
URL
http://www.eye-center.org
Description
Related Info
Learn more about this trial
Submacular Hemorrhage Associated With Retinal Arterial Macro Aneurysm
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