Clinical trial NCT01080898: Evaluation of Optical Coherence Tomography.
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Choroidal Vessels; Anastomosis
Keywords: Age - Related Macular Degeneration
Optical Coherence Tomography
Choroidal neovascularization
FLORESCEIN Angiography
Fundus photographs
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2010-03-04
Enrollment: 151
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: patients \> 50 years with suspicion of choroidal neo-vessels complicating age relatid macular degeneration (DMLA)

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.

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
* 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

Primary outcomes:
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.
timeFrame: all outcome the day of inclusion
Secondary outcomes:
measure: 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.
timeFrame: all the outcome the day of inclusion
measure: Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography, and of fluorescein angiography combined with fundus color photography.
timeFrame: all outcome the day of inclusion
measure: Rate of unusable images for each technique
timeFrame: all outcome the day of inclusion
measure: Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels
timeFrame: all outcome the day of inclusion
measure: Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels.
timeFrame: all outcome the day of inclusion
measure: 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.
timeFrame: all outcome the day of inclusion
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Ramin TADAYONI, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: