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Completed

NCT Number: NCT02148497

Multi-Colored Placido Disk Viability

The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.

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Key information

Conditions

Dry Eye Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Dry Eye Syndromes Eye Diseases Healthy Immune System Diseases Joint Diseases Lacrimal Apparatus Diseases Mouth Diseases Musculoskeletal Diseases Rheumatic Diseases Salivary Gland Diseases Sjogren's Disease Sjogren's Syndrome Skin and Connective Tissue Diseases Stomatognathic Diseases Xerostomia

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Flaum Eye Institute at the University of Rochester

Rochester, New York, 14642, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Multi-colored Placido disk imaging

Procedure

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

Primary outcomes

  1. Tear film break-up time

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2018
Study completion
2018
First posted
May 28, 2014
Registry last updated
Oct 5, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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