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High Resolution Retinal Imaging (AOSLO)

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ClinicalTrials.gov Identifier: NCT01866371
Recruitment Status : Recruiting
First Posted : May 31, 2013
Last Update Posted : March 1, 2023
Sponsor:
Collaborator:
National Eye Institute (NEI)
Information provided by (Responsible Party):
University of Pennsylvania

Study Description
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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.

Condition or disease Intervention/treatment
Stargardts Retinitis Pigmentosa Age-related Macular Degeneration Choroideremia Geographic Atrophy Procedure: Retinal imaging

Study Design
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Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: High Resolution Retinal Imaging
Study Start Date : May 2013
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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.
 Procedure: Retinal imaging
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.
 Procedure: Retinal imaging
Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01866371


Contacts
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Contact: Jessica IW Morgan, PhD 215-614-4196 jwmorgan@pennmedicine.upenn.edu

Locations
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United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica IW Morgan, PhD    215-614-4196    jwmorgan@pennmedicine.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
National Eye Institute (NEI)
Investigators
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Principal Investigator: Jessica IW Morgan, PhD University of Pennsylvania
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01866371    
Other Study ID Numbers: 817019
R24EY019861 ( U.S. NIH Grant/Contract )
First Posted: May 31, 2013    Key Record Dates
Last Update Posted: March 1, 2023
Last Verified: February 2023
Keywords provided by University of Pennsylvania:
Retina
imaging
retinal degeneration
Additional relevant MeSH terms:
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Macular Degeneration
Retinitis
Retinitis Pigmentosa
Geographic Atrophy
Choroideremia
Retinal Degeneration
Retinal Diseases
 Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Genetic Diseases, Inborn
Choroid Diseases
Uveal Diseases
Genetic Diseases, X-Linked