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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
  Purpose
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.

Condition Intervention
Age-Related Macular Degeneration Choroidal Vessels; Anastomosis Other: tests

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Assistance Publique - Hôpitaux de Paris:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 151
Study Start Date: April 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients > 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01080898


Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
Principal Investigator: Ramin TADAYONI, MD,PhD Assistance Publique - Hôpitaux de Paris
  More Information

Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT01080898     History of Changes
Other Study ID Numbers: K080904
IDRCB 2009-A00670-57 ( Other Identifier: AFSSAPS )
First Submitted: January 28, 2010
First Posted: March 4, 2010
Last Update Posted: July 23, 2012
Last Verified: April 2011

Keywords provided by Assistance Publique - Hôpitaux de Paris:
Age - Related Macular Degeneration
Optical Coherence Tomography
Choroidal neovascularization
FLORESCEIN Angiography
Fundus photographs

Additional relevant MeSH terms:
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases