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OpenTrials
Completed

NCT Number: NCT00797524

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

AIBILI

Coimbra, Coimbra District, 3000-548, Portugal

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Retinal leakage and retinal thickness.

    Time frame: After the visit

Sponsors and collaborators

Lead sponsor

Association for Innovation and Biomedical Research on Light and Image

Other

Registry information

Official study title

Function and Structure Imaging in Different Retinal Diseases. Retinal Leakage Analyzer vs. Optical Coherence Tomography.

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Nov 25, 2008
Registry last updated
Feb 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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