Novel Glaucoma Diagnostics

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Wills Eye
Study ID
NCT00286637
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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

Key Dates

Start date
Aug 1, 2000
Status verified
Aug 2024
Primary completion
Jul 31, 2029
Completion
Jul 31, 2029

Study Design

Enrollment
5,000 participants (estimated)

Arms

  • Arm: 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.
  • Arm: 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.
  • Arm: 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.
  • Arm: 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.

Primary Outcome Measure

Number of Participants who Show Evidence of Glaucoma Progression [ Time Frame: Up to Year 5 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Wills Eye HospitalPhiladelphiaPennsylvania19107
Taylor Harwood
215-928-3197
Ronald Zambrano
215-928-3197
Joel S Schuman, MD (PRINCIPAL_INVESTIGATOR)
Gadi Wollstein, MD (SUB_INVESTIGATOR)

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