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Evaluation of Optical Coherence Tomography. (ESSO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01080898
First Posted: March 4, 2010
Last Update Posted: July 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris
January 28, 2010
March 4, 2010
July 23, 2012
April 2010
October 2010   (Final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01080898 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: 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. [ Time Frame: all outcome the day of inclusion ]
  • Rate of unusable images for each technique [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: 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. [ Time Frame: all outcome the day of inclusion ]
Same as current
Not Provided
Not Provided
 
Evaluation of Optical Coherence Tomography.
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.
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.
Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Probability Sample
patients > 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)
  • Age-Related Macular Degeneration
  • Choroidal Vessels; Anastomosis
Other: tests
color photographs, FLUORESCEIN angiography and OCT
DMLA patients
patients > 50 years with suspicion of choroidal neo-vessels complicating age related macular degeneration (DMLA)
Intervention: Other: tests
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
151
October 2010
October 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
France
 
NCT01080898
K080904
IDRCB 2009-A00670-57 ( Other Identifier: AFSSAPS )
No
Not Provided
Not Provided
Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
Not Provided
Principal Investigator: Ramin TADAYONI, MD,PhD Assistance Publique - Hôpitaux de Paris
Assistance Publique - Hôpitaux de Paris
April 2011