Evaluation of Optical Coherence Tomography. (ESSO)

Evaluation of the Sensitivity and Specificity of Optical Coherence Tomography Combined With Fundus Color Photos for Diagnosis of Choroidal Neovessels in Age-related Macular Degeneration

Determination of the sensitivity and specificity of different combinations of imaging techniques (spectral domain optical coherence tomography, fundus photography and fluorescein angiography) used for the diagnosis of choroidal neovessels complicating age -related macular degeneration. This information will help to determine the choice of the most suitable combination for the above diagnosis.

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration; Choroidal Vessels; Anastomosis
• Intervention / Treatment: Other: tests

Detailed Description

The following combinations will be studied: spectral domain optical coherence tomography (OCT) + fundus photography; fluorescein angiography + fundus photography and the combination of all three techniques (OCT+ fundus photography + fluorescein angiography).The sensitivity and specificity of the latter combination will be assessed by comparison with the results for this combination reported by several readers. Inter- and intra-observer reproducibility of the different combinations will also be studied.

• Study Type: Observational
• Enrollment (Actual): 151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

patients > 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)

Description

Inclusion Criteria:

• Age> 50 years
• First visit for suspicion of choroidal neo-vessels complicating age related macular degeneration
• Fundus color photographs , FLUORESCEIN angiography and OCT prescription

Exclusion Criteria:

• Age < 50 years
• Diabetes
• Central vein occlusion Macular hole Epi-retinal membrane Retinal detachment Macular hemorrhage more than the 1/3 of the lesion
• History of macular laser, PDT or intra-vitreal injection

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DMLA patients; patients > 50 years with suspicion of choroidal neo-vessels complicating age related macular degeneration (DMLA)	Other: tests; color photographs, FLUORESCEIN angiography and OCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photos in the diagnosis of choroidal neovessels in age- related macular degeneration.	all outcome the day of inclusion

Secondary Outcome Measures

Outcome Measure	Time Frame
Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography in the diagnosis of choroidal neovessels in age - related macular degeneration.	all the outcome the day of inclusion
Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography, and of fluorescein angiography combined with fundus color photography.	all outcome the day of inclusion
Rate of unusable images for each technique	all outcome the day of inclusion
Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels	all outcome the day of inclusion
Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels.	all outcome the day of inclusion
Evaluation of the intra-and inter-reader reproducibility of the diagnosis of choroidal neovessels in age-related macular degeneration using fluorescein angiography combined with fundus color photography.	all outcome the day of inclusion

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Ramin TADAYONI, MD,PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start: April 1, 2010
• Primary Completion (Actual): October 1, 2010
• Study Completion (Actual): October 1, 2010

Study Registration Dates

• First Submitted: January 28, 2010
• First Submitted That Met QC Criteria: March 3, 2010
• First Posted (Estimate): March 4, 2010

Study Record Updates

• Last Update Posted (Estimate): July 23, 2012
• Last Update Submitted That Met QC Criteria: July 20, 2012
• Last Verified: April 1, 2011

More Information

Terms related to this study

• Keywords: Optical Coherence Tomography; Choroidal neovascularization; Fundus photographs; Age - Related Macular Degeneration; FLORESCEIN Angiography
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: K080904; IDRCB 2009-A00670-57 (Other Identifier: AFSSAPS)