High Resolution Retinal Imaging

Recruiting

• Conditions: Age-related Macular Degeneration; Choroideremia; Geographic Atrophy; Retinitis Pigmentosa; Stargardts
• Interventions: Procedure: Retinal imaging

• Registration Number: NCT01866371
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-05-28
• Study First Submitted QC: 2013-05-30
• Study First Posted: 2013-05-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-26
• Last Update Posted: 2024-03-28
• Primary Completion: 2026-12
• Study Completion: 2027-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 600

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Normal control	Retinal imaging	This group will include individuals without retinal degeneration. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity.
Retinal degeneration	Retinal imaging	This group will include patients with retinal degeneration and vision abnormalities. The group will participate in retinal imaging procedures including adaptive optics imaging, optical coherence tomography and fundus photography. Vision may be assessed using microperimetry, visual fields, and visual acuity.

Primary Outcome Measures

Name	Time	Method
high-resolution images of retina	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 Outcome Measures

Name	Time	Method
Cone mosaic parameters	1 day (initial visit)	Imaging the cone photoreceptor mosaic, and analyzing cell density, size, spacing, regularity, and other mosaic parameters in normal retina compared to diseased retina.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States