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Multi-Colored Placido Disk Viability

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02148497
Enrollment
16
Registered
2014-05-28
Start date
2014-05-31
Completion date
2018-09-30
Last updated
2018-10-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dry Eye, Healthy, Sjogren's Disease

Keywords

volunteers

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.

Interventions

PROCEDUREMulti-colored Placido disk imaging

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

Sponsors

University of Rochester
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Tear film break-up timeup to 3 secondsThe 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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026