Clinical trial NCT01866371: High Resolution Retinal Imaging
Official title: High Resolution Retinal Imaging
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stargardts
Retinitis Pigmentosa
Age-related Macular Degeneration
Choroideremia
Geographic Atrophy
Keywords: Retina
imaging
retinal degeneration
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Eye Institute (NEI)
First posted: 2013-05-31
Enrollment: 600
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: high-resolution images of retina
timeFrame: 1 day (initial visit)
Secondary outcomes:
measure: Cone mosaic parameters
timeFrame: 1 day (initial visit)
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Jessica IW Morgan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.