Novel Diagnostics for Ocular Structure

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

The purpose of this research is to evaluate novel technologies for the assessment of ocular structure and function, including the scanning device called Optical Coherence Tomography (OCT). We will test the OCT and other devices in their ability to image diseases of the eye and also compare the measurements made with OCT to those of other imaging and visual field devices approved by the Food and Drug Administration (FDA). OCT may be useful for the early diagnosis and monitoring of a variety of types of eye diseases

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• Ability to provide informed consent and to understand the study procedures

• Healthy volunteers

• Age related macular degeneration (AMD), diabetic retinopathy, central serous chorioretinopathy, and/or glaucoma or glaucoma suspects

• (AD Sub-Study ONLY): Subjects diagnosed with AD or MCI.

Locations
United States
Pennsylvania
Wills Eye Hospital
RECRUITING
Philadelphia
Contact Information
Primary
Taylor Harwood
tharwood@willseye.org
215-928-3197
Backup
Ronald Zambrano
rzambrano@willseye.org
215-928-3197
Time Frame
Start Date: 2000-08-01
Estimated Completion Date: 2029-07-31
Participants
Target number of participants: 5000
Treatments
Cross-Sectional Study
Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule.
Longitudinal Study
Subjects will undergo a comprehensive ocular examination at every visit. Frequency of the visits is dictated by the treating physician, disregarding participation in the study. In glaucoma clinic patients are typically scheduled for visits every six months, and the frequency of visits varies according to clinical severity in the retina clinic. No additional research visits are required beyond the clinically dictated schedule.
Reproducibility Study
Subjects willing to participate in the reproducibility arm of the project will undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms. However, OCT scanning will be repeated up to five times within a single visit. The participants will be requested to repeat the visual field and OCT scanning in up to 5 additional independent visits within a month to minimize the possibility that an actual change in ocular structures has occurred. Duration of each additional visit will be up to 45 minutes.
Alzheimer's Disease (AD) Sub-Study
Participants with AD or mild cognitive impairment (MCI) undergo the same comprehensive ocular examination as in the longitudinal and cross-sectional study arms.
Authors
Hiroshi Ishikawa, Ian Conner
Sponsors
Leads: Wills Eye
Collaborators: National Eye Institute (NEI)

This content was sourced from clinicaltrials.gov