- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01866371
High Resolution Retinal Imaging (AOSLO)
March 26, 2024 updated by: University of Pennsylvania
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
600
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jessica IW Morgan, PhD
- Phone Number: 215-614-4196
- Email: jwmorgan@pennmedicine.upenn.edu
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- University of Pennsylvania
-
Contact:
- Jessica IW Morgan, PhD
- Phone Number: 215-614-4196
- Email: jwmorgan@pennmedicine.upenn.edu
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
7 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study 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.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
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 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 procedures include adaptive optics imaging, optical coherence tomography and fundus photography.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
1 day (initial visit)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cone mosaic parameters
Time Frame: 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.
|
1 day (initial visit)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jessica IW Morgan, PhD, University of Pennsylvania
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2027
Study Registration Dates
First Submitted
May 28, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (Estimated)
May 31, 2013
Study Record Updates
Last Update Posted (Actual)
March 28, 2024
Last Update Submitted That Met QC Criteria
March 26, 2024
Last Verified
March 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 817019
- R24EY019861 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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