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OpenTrials
Completed

NCT Number: NCT01080898

Evaluation of Optical Coherence Tomography.

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.

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Key information

Conditions

Age-Related Macular Degeneration Choroid Diseases Choroidal Neovascularization Choroidal Vessels; Anastomosis Eye Diseases Macular Degeneration Metaplasia Neovascularization, Pathologic Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Degeneration Retinal Diseases Uveal Diseases

Age range

50 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tests

Other

color photographs, FLUORESCEIN angiography and OCT

Primary outcomes

  1. 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

  1. 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

  2. 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

  3. Rate of unusable images for each technique

    Time frame: all outcome the day of inclusion

  4. 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

  5. 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

  6. 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

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study 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

Acronym: ESSO

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Mar 4, 2010
Registry last updated
Jul 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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