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Retinal Thickness Analysis Using Optical Coherence Tomography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00797134
Recruitment Status : Completed
First Posted : November 25, 2008
Last Update Posted : February 3, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.


Condition or disease
Diabetic Retinopathy

Study Design

Study Type : Observational
Actual Enrollment : 45 participants
Observational Model: Cohort
Official Title: Retinal Thickness Analysis Using Optical Coherence Tomography
Study Start Date : November 2008
Primary Completion Date : July 2010
Study Completion Date : July 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
DR
Diabetic Retinopathy


Outcome Measures

Primary Outcome Measures :
  1. Retinal thickness. [ Time Frame: After visit(s) ]

Secondary Outcome Measures :
  1. Choroidal Thickness [ Time Frame: After visit(s) ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Subjects followed regularly by their ophthalmologist performing, as part of their follow-up, optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00797134


Locations
Portugal
AIBILI
Coimbra, Portugal, 3000-548
Sponsors and Collaborators
Association for Innovation and Biomedical Research on Light and Image
Investigators
Principal Investigator: José Cunha-Vaz, MD, PhD Association for Innovation and Biomedical Research on Light and Image
More Information

Additional Information:
Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00797134     History of Changes
Other Study ID Numbers: CNTM025AOCT
First Posted: November 25, 2008    Key Record Dates
Last Update Posted: February 3, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Diabetic Retinopathy
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases