Dry EyeNCT02148497
Multi-Colored Placido Disk Viability
A study testing Multi-colored Placido disk imaging in people with Dry Eye and Sjogren's Disease, run by University of Rochester at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Dry Eye, Sjogren's Disease, Healthy
- What is being tested?
- Multi-colored Placido disk imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- May 2014to Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Flaum Eye Institute at the University of Rochester
Rochester, New York, 14642
About this study
Official title: Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data
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
- Being tested
- Multi-colored Placido disk imaging
- Keywords
- volunteers
- Medical subject headings
- Dry Eye Syndromes, Sjogren's Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi-colored Placido disk imagingProcedure or surgery
The multi-colored Placido disk instrument records the tear surface using video imaging.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye Disease or Sjogren's Disease | Other | Capturing images of the tear surface using the multi-colored Placido disk Receives: Procedure: Multi-colored Placido disk imaging |
| Control | Other | Capturing images of the tear surface using the multi-colored Placido disk Receives: Procedure: Multi-colored Placido disk imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 3 seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2014 (estimated)
- Study startMay 2014
- Primary completionSep 2018
- Study completionSep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry EyeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Geunyoung Yoon, University of Rochester
- Investigators
- Geunyoung Yoon, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02148497
- Sponsor's protocol ID
- 51771
- Status last verified
- Oct 2018
- First submitted
- 15 Apr 2014
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Viability Study of a Multi-Colored Videokeratoscope With Extended Timescale Data
- ClinicalTrials.gov ID
- NCT02148497
- Acronym / sponsor ID
- 51771
- Conditions
- Dry Eye, Sjogren's Disease, Healthy
- Keywords
- volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Sep 2018 (actual)
- Study completion
- Sep 2018 (actual)
- First posted
- 28 May 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to show that the multi-colored Placido Disk set-up can get reliable data over long time periods.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dry Eye Disease or Sjogren's Disease | Other | Procedure: Multi-colored Placido disk imagingCapturing images of the tear surface using the multi-colored Placido disk |
| Control | Other | Procedure: Multi-colored Placido disk imagingCapturing images of the tear surface using the multi-colored Placido disk |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi-colored Placido disk imagingThe multi-colored Placido disk instrument records the tear surface using video imaging. | Procedure or surgery | Control, Dry Eye Disease or Sjogren's Disease |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geunyoung Yoon, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Multi-colored Placido disk imaging in people with Dry Eye and Sjogren's Disease, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tear film break-up time (time frame: up to 3 seconds). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018; AzTrials last refreshed its copy on 27 Oct 2026.