High Resolution Retinal Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age7+
SponsorUniversity of Pennsylvania

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial population

Individuals age 7 and older will be recruited for purposes of this study. Adults must have the capacity to give informed consent. Subjects age 7 to 17 will need parent/guardian consent to participate in the study. Subjects aged 7 to 17 will need to assent to participate in the study. We will recruit subjects with both normal (disease-free) retinas and subjects with retinal degenerations including Leber's Congenital Amaurosis, Stargardt's Dystrophy, retinitis pigmentosa, age-related macular degeneration, Choroideremia, Geographic Atrophy, etc. Subjects will not be excluded based on ethnic or racial background; we expect that enrollment will be split evenly between males and females.

Trial design

Design model

Case-control

Time perspective

Prospective

Treatments tested in this trial

  • Retinal imaging

    Procedure/Surgery

    Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.

Treatment groups

600 Participants
are divided into 2 treatment groups
Group A: Retinal degeneration1 intervention
Group B: Normal control1 intervention

Trial outcomes

Primary outcomes

1

high-resolution images of retina

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

Time frame
1 day (initial visit)

Secondary outcomes

1

Cone mosaic parameters

Imaging the cone photoreceptor mosaic, and analyzing cell density, size, spacing, regularity, and other mosaic parameters in normal retina compared to diseased retina.

Time frame
1 day (initial visit)

Other outcomes

Sponsors and contacts

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University of Pennsylvania

Lead sponsor

National Eye Institute (NEI)

Collaborator