Dry EyeNCT04457999
Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
A study testing Lipiflow Thermal pulsation in people with Dry Eye, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease Read more about this study
- Who is it for?
- Ages 21 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye
- What is being tested?
- Lipiflow Thermal pulsation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Mar 2020to 30 Jul 2020
- 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 21 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients older than 21, who will get catarct surgeyr
- Patients whose visual acuity anticipated better than 20/25 after surgery
- Patients with informed consent
- Patients with meibomian gland dysfunction
Who cannot join
- ocular injury, active injection
- uncontrolled systemic disease
- Contact lens wear within 1 month
- Allergic to fluorescein sodium or topical anesthetics
- ocular surgery or trauma within 6 months
- disorder of lid anatomy
Show all 9Show fewer
- other reason for decreased vision other than cataract
- anticipated visual acuity less than 20/25
- Patients less than 20 years.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul
Tae-Young Chung, +82-10-9933-3563, tychung@skku.edu
About this study
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease
- Conditions
- Dry Eye
- Being tested
- Lipiflow Thermal pulsation
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lipiflow Thermal pulsationDevice
Single vectored thermal pulsation treatment for dry eye
| Study group | Role | What they receive |
|---|---|---|
| Lipiflow treatment | Experimental | Lipiflow thermal pulsation prior to cataract surgery Receives: Device: Lipiflow Thermal pulsation |
What is being measured
The primary outcome is the main question the study is designed to answer.
improvement of dry eye symptom
ocular dryness
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start20 Mar 2020
- Primary completion2 Jul 2020 (estimated)
- Study completion30 Jul 2020 (estimated)
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.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457999
- Sponsor's protocol ID
- 2019-03-011
- Status last verified
- Jul 2020
- First submitted
- 1 Jul 2020
- Last updated
- 7 Jul 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcome of Lipiflow Treatment Prior to Cataract Surgery in Dry Eye Patients
- ClinicalTrials.gov ID
- NCT04457999
- Acronym / sponsor ID
- 2019-03-011
- Conditions
- Dry Eye
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 20 Mar 2020 (actual)
- Primary completion
- 2 Jul 2020 (estimated)
- Study completion
- 30 Jul 2020 (estimated)
- First posted
- 7 Jul 2020 (actual)
- 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.
To investigate the clinical outcome of Lipiflow treatment prior to cataract surgery in patients with meibomian gland dysfunction and dry eye disease
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Lipiflow treatment | Experimental | Device: Lipiflow Thermal pulsationLipiflow thermal pulsation prior to cataract surgery |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients older than 21, who will get catarct surgeyr
- Patients whose visual acuity anticipated better than 20/25 after surgery
- Patients with informed consent
- Patients with meibomian gland dysfunction
Key exclusion criteria (9 listed)
- ocular injury, active injection
- uncontrolled systemic disease
- Contact lens wear within 1 month
- Allergic to fluorescein sodium or topical anesthetics
- ocular surgery or trauma within 6 months
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 |
|---|---|---|
| Lipiflow Thermal pulsationSingle vectored thermal pulsation treatment for dry eye | Device | Lipiflow treatment |
Primary outcome
improvement of dry eye symptom
Time frame: 1 month
ocular dryness
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2020.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lipiflow Thermal pulsation in people with Dry Eye, run by Samsung Medical Center at 1 site in South Korea.
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 4 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 7 Jul 2020. 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 South Korea. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tae-Young Chung, MD. PhD (82-2-3410-3563, tychung@skku.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
improvement of dry eye symptom (time frame: 1 month). 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 7 Jul 2020.