Multi-Colored Placido Disk Viability

NCT ID: NCT02148497

Last Updated: 2018-10-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2018-09-30

Brief Summary

The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.

Conditions

Dry Eye; Sjogren's Disease; Healthy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dry Eye Disease or Sjogren's Disease

Capturing images of the tear surface using the multi-colored Placido disk

Group Type: OTHER

Multi-colored Placido disk imaging

Intervention Type: PROCEDURE

The multi-colored Placido disk instrument records the tear surface using video imaging.

Control

Capturing images of the tear surface using the multi-colored Placido disk

Group Type: OTHER

Multi-colored Placido disk imaging

Intervention Type: PROCEDURE

The multi-colored Placido disk instrument records the tear surface using video imaging.

Interventions

Multi-colored Placido disk imaging

The multi-colored Placido disk instrument records the tear surface using video imaging.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects must have clinically diagnosed Dry Eye or Sjörgren's syndrome.
• Good general health (defined by medication use that has not changed within the last month and the absence of medical conditions that are deemed confounding to the data as determined by the PI)
• Ability to give informed consent
• Willing to spend time for the study; approximately 30 minutes for a visit
• Either gender
• Any racial or ethnic origin

Exclusion Criteria

• Use of any prescription ocular medication (such as but not limited to, glaucoma medications and Restasis) used within 14 days of the screening visit or started prior to the measurement visit(s).
• Current eye disease, infection or inflammation that affects the surface of the eye such as, but not limited to blepharitis and ocular allergy.
• Past eye surgery, such as, but not limited to, refractive surgery. Subjects who have had cataract surgery less than one year ago.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Geunyoung Yoon

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Geunyoung Yoon, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

Flaum Eye Institute at the University of Rochester

Rochester, New York, United States

Countries

United States

Other Identifiers

51771

Identifier Type: -

Identifier Source: org_study_id