High Resolution Retinal Imaging

NCT ID: NCT01866371

Last Updated: 2025-04-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2027-12-31

Brief Summary

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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

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Conditions

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Stargardts Retinitis Pigmentosa Age-related Macular Degeneration Choroideremia Geographic Atrophy

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Retinal degeneration

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.

Retinal imaging

Intervention Type PROCEDURE

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

Normal control

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 imaging

Intervention Type PROCEDURE

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

Interventions

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Retinal imaging

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

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Eye Institute (NEI)

NIH

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jessica IW Morgan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

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University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Jessica IW Morgan, PhD

Role: CONTACT

215-614-4196

Facility Contacts

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Jessica IW Morgan, PhD

Role: primary

215-614-4196

References

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Morgan JI, Han G, Klinman E, Maguire WM, Chung DC, Maguire AM, Bennett J. High-resolution adaptive optics retinal imaging of cellular structure in choroideremia. Invest Ophthalmol Vis Sci. 2014 Sep 4;55(10):6381-97. doi: 10.1167/iovs.13-13454.

Reference Type DERIVED
PMID: 25190651 (View on PubMed)

Other Identifiers

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R24EY019861

Identifier Type: NIH

Identifier Source: secondary_id

View Link

817019

Identifier Type: -

Identifier Source: org_study_id

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