Evaluation of Optical Coherence Tomography. (ESSO)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Assistance Publique - Hôpitaux de Paris

ClinicalTrials.gov Identifier:

NCT01080898

First received: January 28, 2010

Last updated: July 20, 2012

Last verified: April 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

January 28, 2010

Last Updated Date

July 20, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01080898 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Rate of unusable images for each technique [ Time Frame: all outcome the day of inclusion ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Evaluation of Optical Coherence Tomography.

Official Title ^ICMJE

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

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 Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Cross-Sectional

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Probability Sample

Study Population

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

Condition ^ICMJE

Age-Related Macular Degeneration
Choroidal Vessels; Anastomosis

Intervention ^ICMJE

Other: tests

color photographs, FLUORESCEIN angiography and OCT

Study Group/Cohort (s)

DMLA patients

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

Intervention: Other: tests

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

151

Completion Date

October 2010

Primary Completion Date

October 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

50 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01080898

Other Study ID Numbers ^ICMJE

K080904, IDRCB 2009-A00670-57

Has Data Monitoring Committee

Responsible Party

Assistance Publique - Hôpitaux de Paris

Study Sponsor ^ICMJE

Assistance Publique - Hôpitaux de Paris

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Ramin TADAYONI, MD,PhD

Assistance Publique - Hôpitaux de Paris

Information Provided By

Assistance Publique - Hôpitaux de Paris

Verification Date

April 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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