Evaluation of Optical Coherence Tomography.

Age-Related Macular Degeneration Clinical Trial

— ESSO  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080898
• Other study ID #: K080904
• Secondary ID: IDRCB 2009-A0067
• Status: Completed
• Phase: N/A
• First received: January 28, 2010
• Last updated: July 20, 2012
• Start date: April 2010
• Est. completion date: October 2010

Study information

• Verified date: April 2011
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 151
• Est. completion date: October 2010
• Est. primary completion date: October 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Choroidal Vessels; Anastomosis
• Macular Degeneration

Intervention

Other:
• tests
color photographs, FLUORESCEIN angiography and OCT

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		all outcome the day of inclusion	No
Secondary	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.		all the outcome the day of inclusion	No
Secondary	Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography, and of fluorescein angiography combined with fundus color photography.		all outcome the day of inclusion	No
Secondary	Rate of unusable images for each technique		all outcome the day of inclusion	No
Secondary	Evaluation of the sensitivity and specificity of optical coherence tomography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels		all outcome the day of inclusion	No
Secondary	Evaluation of the sensitivity and specificity of fluorescein angiography combined with fundus color photography for the diagnosis of sub-categories of choroidal neovessels.		all outcome the day of inclusion	No
Secondary	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.		all outcome the day of inclusion	No