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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01792141

Enrollment

Registered

2013-02-15

Start date

2011-01-31

Completion date

2012-12-31

Last updated

2013-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Macular Edema

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Meets criteria for Clinically Significant Macular Edema * Microaneurysms hyperfluorescent

Exclusion criteria

* Increase intraocular pressure * Intraocular inflammation * Retinal detachment

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

United States

Outcome results