High Resolution Retinal Imaging
AOSLO
2 other identifiers
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2013
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
May 28, 2013
CompletedFirst Posted
Study publicly available on registry
May 31, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2031
May 5, 2026
April 1, 2026
17.6 years
May 28, 2013
April 28, 2026
Conditions
Keywords
Outcome Measures
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.
1 day (initial visit)
Secondary Outcomes (1)
Cone mosaic parameters
1 day (initial visit)
Study Arms (2)
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.
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.
Interventions
Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Eye Institute (NEI)collaborator
- University of Pennsylvanialead
Study Sites (1)
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Related Publications (1)
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.
PMID: 25190651DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jessica IW Morgan, PhD
University of Pennsylvania
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 28, 2013
First Posted
May 31, 2013
Study Start
May 1, 2013
Primary Completion (Estimated)
December 1, 2030
Study Completion (Estimated)
December 1, 2031
Last Updated
May 5, 2026
Record last verified: 2026-04