High Resolution Retinal Imaging (AOSLO)

This study is currently recruiting participants.
Verified May 2013 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01866371
First received: May 28, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose

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 Intervention
Stargardts
Retinitis Pigmentosa
Age-related Macular Degeneration
Choroideremia
Geographic Atrophy
Procedure: Retinal imaging

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: High Resolution Retinal Imaging

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • high-resolution images of retina [ Time Frame: 1 day (initial visit) ] [ Designated as safety issue: No ]
    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:
  • Cone mosaic parameters [ Time Frame: 1 day (initial visit) ] [ Designated as safety issue: No ]
    Imaging the cone photoreceptor mosaic, and analyzing cell density, size, spacing, regularity, and other mosaic parameters in normal retina compared to diseased retina.


Estimated Enrollment: 600
Study Start Date: May 2013
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01866371

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

Locations
United States, Pennsylvania
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Jessica IW Morgan, PhD    215-614-4196    jwmorgan@mail.med.upenn.edu   
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Jessica IW Morgan, PhD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01866371     History of Changes
Other Study ID Numbers: 817019, R24EY019861
Study First Received: May 28, 2013
Last Updated: May 30, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
Retina
imaging
retinal degeneration

Additional relevant MeSH terms:
Choroideremia
Macular Degeneration
Retinitis
Retinitis Pigmentosa
Atrophy
Geographic Atrophy
Eye Diseases, Hereditary
Eye Diseases
Choroid Diseases
Uveal Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Retinal Degeneration
Retinal Diseases
Retinal Dystrophies
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 16, 2014