Use of Diagnostic Dye to Identify Areas of Leakeage,in the Retina, Prior to Receiving Focal Laser Treatment
The Use of Fluorescein-Indocyanine Green Angiography in Patients With Diabetic Macular Edema to Identify Areas of Increased Leakage and Provide Targeted Focal Laser Treatment.
1 other identifier
observational
50
1 country
1
Brief Summary
The use of Indocyanine green diagnostic dye will identify areas of vascular leakage which will provide more effective laser treatment by targeting these specific areas.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 11, 2013
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedFebruary 15, 2013
February 1, 2013
1.4 years
February 11, 2013
February 12, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
Primary objective is to assess the effectiveness of FA-ICG guided focal laser therapy for the treatment CSME by means of serial FA-1CGs before and every 3 months after treatment.
Visual Acuity will be measured by using the Early Treatment Diabetic Retinopathy Study. (ETDRS) Macular volume will be measured by Optical coherence tomography.
3 months
Eligibility Criteria
Patients with Clinically Significant Macular Edema
You may qualify if:
- Meets criteria for Clinically Significant Macular Edema
- Microaneurysms hyperfluorescent
You may not qualify if:
- Increase intraocular pressure
- Intraocular inflammation
- Retinal detachment
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Retina Institute of Hawaii
Honolulu, Hawaii, 96815, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael D Bennett, MD
Retina Institute of Hawaii
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 11, 2013
First Posted
February 15, 2013
Study Start
January 1, 2011
Primary Completion
June 1, 2012
Study Completion
December 1, 2012
Last Updated
February 15, 2013
Record last verified: 2013-02