High Resolution Retinal Imaging

Age-related Macular Degeneration Clinical Trial

— AOSLO  

Official title:

High Resolution Retinal Imaging

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01866371
• Other study ID #: 817019
• Secondary ID: R24EY019861
• Status: Recruiting
• Start date: May 2013
• Est. completion date: December 2027

Study information

• Verified date: March 2024
• Source: University of Pennsylvania
• Contact: Jessica IW Morgan, PhD
• Phone: 215-614-4196
• Email: jwmorgan[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 2027
• Est. primary completion date: December 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 7 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Choroideremia
• Geographic Atrophy
• Macular Degeneration
• Retinitis
• Retinitis Pigmentosa
• Stargardts

Intervention

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

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	National Eye Institute (NEI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	high-resolution images of retina	The primary objective of this study is to obtain and analyze high-resolution images of the retina in normal and diseased eyes non-invasively.	1 day (initial visit)
Secondary	Cone mosaic parameters	Imaging the cone photoreceptor mosaic, and analyzing cell density, size, spacing, regularity, and other mosaic parameters in normal retina compared to diseased retina.	1 day (initial visit)