Novel Glaucoma Diagnostics
Part of paid clinical trials in Philadelphia, Pennsylvania.
- Sponsor
- Wills Eye
- Study ID
- NCT00286637
- Status
- Recruiting
Conditions
- Glaucoma
- Macular Disease
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 StudySubjects 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 StudySubjects 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 StudySubjects 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-StudyParticipants 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
- Taylor Harwood215-928-3197
- Ronald Zambrano215-928-3197
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Wills Eye Hospital | Philadelphia | Pennsylvania | 19107 | Joel S Schuman, MD (PRINCIPAL_INVESTIGATOR) Gadi Wollstein, MD (SUB_INVESTIGATOR) |
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