Evaluation of Optical Coherence Tomography.

Completed

• Conditions: Age-Related Macular Degeneration; Choroidal Vessels; Anastomosis
• Interventions: Other: tests

• Registration Number: NCT01080898
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-01-28
• Study First Submitted QC: 2010-03-03
• Study First Posted: 2010-03-04
• Study Start: 2010-04
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-04
• Last Update Submitted: 2012-07-20
• Last Update Posted: 2012-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 151

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DMLA patients	tests	patients \> 50 years with suspicion of choroidal neo-vessels complicating age related macular degeneration (DMLA)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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