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Clinical Trials/NCT01080898
NCT01080898
Completed
Not Applicable

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

Assistance Publique - Hôpitaux de Paris0 sites151 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Age-Related Macular Degeneration
Sponsor
Assistance Publique - Hôpitaux de Paris
Enrollment
151
Primary Endpoint
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.
Status
Completed
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
October 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • 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

Outcomes

Primary Outcomes

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.

Time Frame: all outcome the day of inclusion

Secondary Outcomes

  • 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)

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