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Clinical Trials/NCT00797134
NCT00797134
Completed
Not Applicable

Retinal Thickness Analysis Using Optical Coherence Tomography

Association for Innovation and Biomedical Research on Light and Image1 site in 1 country45 target enrollmentNovember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diabetic Retinopathy
Sponsor
Association for Innovation and Biomedical Research on Light and Image
Enrollment
45
Locations
1
Primary Endpoint
Retinal thickness.
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

The main objective of this study is to characterize and correlate diabetic macular edema (DME), i.e. increased retinal thickness, measured by Optical Coherence Tomograph (OCT), and retinal visual function.

The secondary objectives of this study are the analysis and characterization of DME progression over time (between two visits), and the comparison of OCT data obtained with different devices.

The results of this study will be used exclusively for scientific purposes.

Registry
clinicaltrials.gov
Start Date
November 2008
End Date
July 2010
Last Updated
11 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Association for Innovation and Biomedical Research on Light and Image
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Diagnosis of DR
  • Females or Males
  • Age over 18 years
  • Signed Informed Consent Form

Exclusion Criteria

  • Cataract or other eye disease that may interfere with fundus examinations
  • Vitreous syneresis or posterior vitreous detachment
  • Dilatation of the pupil \< 5 mm

Outcomes

Primary Outcomes

Retinal thickness.

Time Frame: After visit(s)

Secondary Outcomes

  • Choroidal Thickness(After visit(s))

Study Sites (1)

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