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

February 12, 2013 updated by: Retina Institute of Hawaii

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.

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Hawaii
      • Honolulu, Hawaii, United States, 96815
        • Retina Institute of Hawaii

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Clinically Significant Macular Edema

Description

Inclusion Criteria:

  • Meets criteria for Clinically Significant Macular Edema
  • Microaneurysms hyperfluorescent

Exclusion Criteria:

  • Increase intraocular pressure
  • Intraocular inflammation
  • Retinal detachment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 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.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Retina Institute of Hawaii

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (ACTUAL)

June 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

February 11, 2013

First Submitted That Met QC Criteria

February 12, 2013

First Posted (ESTIMATE)

February 15, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 12, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RIH 1010

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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