Function and Structure Imaging in Different Retinal Diseases: Retinal Leakage Analyzer Versus Optical Coherence Tomography

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2010 by Association for Innovation and Biomedical Research on Light and Image.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Association for Innovation and Biomedical Research on Light and Image
ClinicalTrials.gov Identifier:
NCT00797524
First received: November 24, 2008
Last updated: October 13, 2010
Last verified: October 2010
  Purpose

The main objective of this observational study is to characterize and correlate functional and structural changes at the retinal level using the Retinal Leakage Analyzer (RLA) and the Optical Coherence Tomograph (OCT).

To show if it is possible to use OCT as an indirect measurement of leakage, this study will check, in a primary analysis, for OCT changes between fluorescein leaking and non-leaking areas (identified by Retinal Leakage Analyzer).

As a secondary objective, changes in RLA and OCT over time (between two consecutive visits) will be analyzed and characterized.

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


Condition
Diabetic Retinopathy
Age-Related Macular Degeneration
Macular Edema

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. 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 leakage and retinal thickness. [ Time Frame: After the visit ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: November 2008
Estimated Study Completion Date: December 2011
Groups/Cohorts
DR
Diabetic Retinopathy
ARMD
Age-Related Macular Degeneration
ME
Macular Edema

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Subjects followed regularly by their ophthalmologist at the AIBILI Clinical Trial Center (Azinhaga de Santa Comba - Celas, Coimbra, Portugal), performing, as part of their follow-up, fluorescein angiography with the Heidelberg Retina Angiograph (HRA) and optical coherence tomography with OCT, and fulfilling the inclusion/exclusion criteria will be included.

Criteria

Inclusion Criteria:

  • Diagnosis of DR, ARMD or ME
  • 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00797524

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 by Association for Innovation and Biomedical Research on Light and Image

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: José Cunha-Vaz, MD, PhD, AIBILI
ClinicalTrials.gov Identifier: NCT00797524     History of Changes
Other Study ID Numbers: 023RLAOCT
Study First Received: November 24, 2008
Last Updated: October 13, 2010
Health Authority: Portugal: Health Ethic Committee

Additional relevant MeSH terms:
Diabetic Retinopathy
Edema
Macular Degeneration
Macular Edema
Retinal Diseases
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Signs and Symptoms
Retinal Degeneration

ClinicalTrials.gov processed this record on September 14, 2014