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Recruiting NCT01866371

High Resolution Retinal Imaging

Observational Stargardts Retinitis Pigmentosa Age-related Macular Degeneration Choroideremia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Retinal imaging.
Who it may be relevant to
Registry conditions: Stargardts, Retinitis Pigmentosa, Age-related Macular Degeneration, Choroideremia. Basic parameters: from 7 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Retinal imaging
    Retinal imaging procedures include adaptive optics imaging, optical coherence tomography and fundus photography.

Primary outcome measures

  • high-resolution images of retina [Time frame: 1 day (initial visit)]
Secondary outcome measures (1)
  • Cone mosaic parameters [Time frame: 1 day (initial visit)]

Eligibility 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Case-control

Study locations

United States · 1 center
  • University of Pennsylvania — Philadelphia

Publications

  • 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 25190651

Identifiers

NCT: NCT01866371 · 817019 · R24EY019861

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗