Multi-Colored Placido Disk Viability

Not Applicable

Completed

• Conditions: Sjogren's Disease; Healthy; Dry Eye
• Interventions: Procedure: Multi-colored Placido disk imaging

• Registration Number: NCT02148497
• Lead Sponsor: University of Rochester

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-04-15
• Study Start: 2014-05
• Study First Submitted QC: 2014-05-27
• Study First Posted: 2014-05-28
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2018-10
• Last Update Submitted: 2018-10-03
• Last Update Posted: 2018-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dry Eye Disease or Sjogren's Disease	Multi-colored Placido disk imaging	Capturing images of the tear surface using the multi-colored Placido disk
Control	Multi-colored Placido disk imaging	Capturing images of the tear surface using the multi-colored Placido disk

Primary Outcome Measures

Name	Time	Method
Tear film break-up time	up to 3 seconds	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.

Trial Locations

Locations (1)

Flaum Eye Institute at the University of Rochester; 🇺🇸 Rochester, New York, United States