AOSLO: High Resolution Retinal Imaging

Sponsor
University of Pennsylvania (Other)
Overall Status
Recruiting
CT.gov ID
NCT01866371
Collaborator
National Eye Institute (NEI) (NIH)
600
1
151
4

Study Details

Study Description

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 Phase
  • Procedure: Retinal imaging

Study Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
High Resolution Retinal Imaging
Study Start Date :
May 1, 2013
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2025

Arms and Interventions

Arm 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

Primary Outcome Measures

  1. 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

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
7 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 University of Pennsylvania Philadelphia Pennsylvania United States 19104

Sponsors and Collaborators

  • University of Pennsylvania
  • National Eye Institute (NEI)

Investigators

  • Principal Investigator: Jessica IW Morgan, PhD, University of Pennsylvania

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01866371
Other Study ID Numbers:
  • 817019
  • R24EY019861
First Posted:
May 31, 2013
Last Update Posted:
Jan 28, 2022
Last Verified:
Jan 1, 2022
Keywords provided by University of Pennsylvania
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2022