Use of Diagnostic Dye to Identify Areas of Leakeage,in the Retina, Prior to Receiving Focal Laser Treatment

Completed

• Conditions: Macular Edema

• Registration Number: NCT01792141
• Lead Sponsor: Retina Institute of Hawaii

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.

Detailed Description

The Early Treatment of Diabetic Retinopathy Study showed that early treatment of Clinically Significant Macular Edema (CSME) with focal and grid laser preserved vision in diabetic patients. Indocyanine Green angiography, which was not available at the time of the Early Treatment Diabetic Retinopathy Study (ETDRS), is now standard-of-care for diagnostic evaluation of the choroidal circulation and is routinely done in combination with Fluorescein angiography for a more complete visualization of retinal pathology. Simultaneous examination of both retinal and choroidal circulation allows for identification of microaneurysms that are hyperfluorescent both on Fluorescein angiography and Indocyanine green angiography. Such microaneurysms are sites of increased vascular leakage and represent a means for providing more effective laser treatment by targeting these areas directly with focal laser.

Study Timeline

• Study Start: 2011-01
• Primary Completion: 2012-06
• Study Completion: 2012-12
• Status Verified: 2013-02
• Study First Submitted: 2013-02-11
• Study First Submitted QC: 2013-02-12
• Last Update Submitted: 2013-02-12
• Study First Posted: 2013-02-15
• Last Update Posted: 2013-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Meets criteria for Clinically Significant Macular Edema
• Microaneurysms hyperfluorescent

Exclusion Criteria

• Increase intraocular pressure
• Intraocular inflammation
• Retinal detachment

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	3 months	Visual Acuity will be measured by using the Early Treatment Diabetic Retinopathy Study. (ETDRS) Macular volume will be measured by Optical coherence tomography.

Trial Locations

Locations (1)

Retina Institute of Hawaii; 🇺🇸 Honolulu, Hawaii, United States