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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02148497
Other study ID # 51771
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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