Retinal Thickness Analysis Using Optical Coherence Tomography

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00797134
First received: November 24, 2008
Last updated: July 5, 2013
Last verified: March 2013
  Purpose

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
Diabetic Retinopathy

Study Type: Observational
Study Design: Observational Model: Cohort
Official Title: Retinal Thickness Analysis Using Optical Coherence Tomography

Resource links provided by NLM:


Further study details as provided by Association for Innovation and Biomedical Research on Light and Image:

Primary Outcome Measures:
  • Retinal thickness. [ Time Frame: After visit(s) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Choroidal Thickness [ Time Frame: After visit(s) ] [ Designated as safety issue: No ]

Estimated Enrollment: 45
Study Start Date: November 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
DR
Diabetic Retinopathy

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier: NCT00797134     History of Changes
Other Study ID Numbers: CNTM025AOCT
Study First Received: November 24, 2008
Last Updated: July 5, 2013
Health Authority: Portugal: Health Ethic Committee

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

ClinicalTrials.gov processed this record on April 17, 2014