Multi-Colored Placido Disk Viability

Healthy Clinical Trial

Official title:

Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148497
• Other study ID #: 51771
• Status: Completed
• Phase: N/A
• Start date: May 2014
• Est. completion date: September 2018

Study information

• Verified date: October 2018
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Dry Eye
• Healthy
• Sjogren's Disease
• Sjogren's Syndrome

Intervention

Procedure:
• Multi-colored Placido disk imaging
The multi-colored Placido disk instrument records the tear surface using video imaging.

Locations

Country	Name	City	State
United States	Flaum Eye Institute at the University of Rochester	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tear film break-up time	The multi-colored Placido disk will collect images of the tear film with the aim to have usable data for more extended periods of time. This instrument measures tear film break-up time in seconds using a video recording of the tear surface.	up to 3 seconds