Recruiting

Glaucoma Diagnostics

Sponsor:

Wills Eye

Code:

NCT00286637

Conditions

Glaucoma

Macular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief 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

Conditions

Glaucoma

Macular Disease

Study ID

NCT00286637

Start date

Aug 1, 2000

Status verified date

Aug, 2024

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Jul 31, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Any medical treatment (e.g., chronic corticosteroid, hydroxychloroquine, chloroquine, thioridazine, canthaxanthine) or conditions that affect VF (e.g., stroke) and retinal thickness other than glaucoma.
  • Strabismus, nystagmus, or any condition that prevents fixation.
  • Presence of any media opacities that hinders clinical view of the fundus, and any intraocular non-glaucomatous abnormality
  • History of ocular trauma or intraocular surgery other than uncomplicated glaucoma interventions or cataract extraction at least 3 months previous to participating in the study.

Study Design

Enrollment

5000 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Taylor Harwood

215-928-3197tharwood@willseye.org

Ronald Zambrano

215-928-3197rzambrano@willseye.org

Locations

Wills Eye Hospital

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Contacts

Taylor Harwood

215-928-3197tharwood@willseye.org

Ronald Zambrano

215-928-3197rzambrano@willseye.org

Principal Investigator:

Joel S Schuman, MD

More Information

Sponsor

Wills Eye

Last update posted

Aug 15, 2024

Last verified

Aug, 2024

Keywords

  • OCT
  • CSLO
  • SLP
  • Perimetry
  • electrophysiology
  • glaucoma
  • macular degeneration
  • retinopathy
  • diabetes
  • macular hole

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Wills Eye on 2024-08-15.