Multi-Colored Placido Disk Viability

NCT02148497 | Completed

• 1 other identifier: 51771
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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

Keywords

volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Dry Eye Disease or Sjogren's Disease

OTHER

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

Procedure: Multi-colored Placido disk imaging

Control

OTHER

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

Procedure: Multi-colored Placido disk imaging

Interventions

Multi-colored Placido disk imaging PROCEDURE

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

Control; Dry Eye Disease or Sjogren's Disease

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Dry Eye Syndromes; Sjogren's Syndrome

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases; Arthritis, Rheumatoid; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Xerostomia; Salivary Gland Diseases; Mouth Diseases; Stomatognathic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Geunyoung Yoon, PhD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: April 15, 2014
• First Posted: May 28, 2014
• Study Start: May 1, 2014
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: October 5, 2018

Record last verified: 2018-10

Locations

US (1)