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Clinical Trials/NCT01866371
NCT01866371
Recruiting
Not Applicable

High Resolution Retinal Imaging

University of Pennsylvania1 site in 1 country600 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stargardts
Sponsor
University of Pennsylvania
Enrollment
600
Locations
1
Primary Endpoint
high-resolution images of retina
Status
Recruiting
Last Updated
last year

Overview

Brief Summary

Studying the morphology and function of the normal and diseased retina in vivo is needed for advancing the detection, diagnosis, and treatment of retinal disease. This protocol uses an adaptive optics scanning laser ophthalmoscope (AOSLO) to image the normal and diseased retina with individual cellular resolution non-invasively. The primary objective of this study is to obtain and analyze high-resolution images of the retina, in particular by imaging the cone photoreceptor mosaic, the retinal vasculature and other retinal layers. The study design will involve case-control studies, where cases are followed over time. Subjects age 7 and older may be invited to participate. The main research procedure involves retinal imaging with the AOSLO. The primary endpoint is the observation of differences in retinal images between subjects with and without retinal diseases. These changes will be quantified by examining the cell density, size, spacing and regularity of the cone photoreceptor mosaic, as well as examining the differences between other retinal layers.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
December 2027
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Males or females age 7 years or older.
  • Parental/guardian permission (informed consent) and if appropriate, child assent. Child subjects age 7-17 must give assent.
  • Reasonable compliance with an imaging protocol as determined by the study personnel.

Exclusion Criteria

  • Individuals that are at risk to acute glaucoma.
  • Individuals that are photophobic and experience adverse psychological reactions to flashes of light.
  • Ocular opacities, high refractive error, and high frequency of nystagmus as determined by the study team.

Outcomes

Primary Outcomes

high-resolution images of retina

Time Frame: 1 day (initial visit)

The primary objective of this study is to obtain and analyze high-resolution images of the retina in normal and diseased eyes non-invasively.

Secondary Outcomes

  • Cone mosaic parameters(1 day (initial visit))

Study Sites (1)

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