Overview

This trial is active, not recruiting.

Conditions dry eye, sjogren's disease, healthy
Treatment multi-colored placido disk imaging
Sponsor University of Rochester
Start date May 2014
End date September 2018
Trial size 20 participants
Trial identifier NCT02148497, 51771

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose diagnostic
Arm
(Other)
Capturing images of the tear surface using the multi-colored Placido disk
multi-colored placido disk imaging
The multi-colored Placido disk instrument records the tear surface using video imaging.
(Other)
Capturing images of the tear surface using the multi-colored Placido disk
multi-colored placido disk imaging
The multi-colored Placido disk instrument records the tear surface using video imaging.

Primary Outcomes

Measure
Tear film break-up time
time frame: up to 3 seconds

Eligibility Criteria

Male or female participants from 18 years up to 89 years old.

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.

Additional Information

Official title Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data
Principal investigator Geunyoung Yoon, PhD
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by University of Rochester.