Dry Eye SyndromesNCT04391907
Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient
A study testing IPL in people with Dry Eye Syndromes, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery. 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 Syndromes
- What is being tested?
- IPL
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSouth Korea
- Study dates
- 3 Mar 2020to 2 Mar 2021
- 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
- A patient at the age of 21 cataract surgery
- A patient has the visual potential of 20/25 or better in each eye after cataract removal
- Dry eye patient by meibomian gland dysfunction
- Written informed consent to surgery and participation in the study
Who cannot join
- Eye damage, active eye infection
- Uncontrolled health problem
- Wear contact lens within one month
- Allergic reactions of fluorescein sodium or ophtalmic anesthetic
- Eye surgery and trauma in the last six months
- Eye disease, structural abnormality
Show all 11Show fewer
- If there is a cause of vision loss other than cataracts
- Under 20/25 expect vision
- Under the age of 20 years of age
- Pregnant woman and lactating woman
- Medical conditions in which IPL is contraindicated
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery
Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.
Read the detailed description
IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.
- Conditions
- Dry Eye Syndromes
- Being tested
- IPL
- 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.
IPLProcedure or surgery
Intense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye.
| Study group | Role | What they receive |
|---|---|---|
| IPL group | Active comparator | Subject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery Receives: Procedure: IPL |
| Non-IPL group | No intervention | Subject who do not have intense pulsed light (IPL) laser before cataract surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
TBUT
tear break-up time
Measured: 3 months
meibomian gland function score
By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.
Measured: 3 months
Secondary outcomes (2)
OSDI
questionnaire to evaluate dry eye symptoms. OSDI grading (0 ~ 100) was as follows: normal (0-12 points), mild (13-22 points), moderate (23-32 points), or severe (33-100 points). Higher score means a worse outcome.
Measured: 3 months
Corneal staining score
Punctate epithelial erosion of cornea will be evaluated with standard classification system(NEI score, National Eye Institute score). It divides the cornea into five sections and assigns a value from 0 (absent) to 3 (severe) to each section, based on the amount, size, and confluence of the PEE, for a maximum of 15 points. Higher score means a worse outcome.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start3 Mar 2020 (estimated)
- Primary completion2 Mar 2021 (estimated)
- Study completion2 Mar 2021 (estimated)
Why it stopped: Due to the covid 19, patient recruiment is not going smoothly, so the study was canceled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye SyndromesStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, tae-young chung, Samsung Medical Center
- Investigators
- Tae-Young Chung, PhD, Study chair, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04391907
- Sponsor's protocol ID
- 2019-07-016
- Status last verified
- May 2022
- First submitted
- 15 May 2020
- Last updated
- 13 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery
- ClinicalTrials.gov ID
- NCT04391907
- Acronym / sponsor ID
- 2019-07-016
- Conditions
- Dry Eye Syndromes
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to the covid 19, patient recruiment is not going smoothly, so the study was canceled.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- 3 Mar 2020 (estimated)
- Primary completion
- 2 Mar 2021 (estimated)
- Study completion
- 2 Mar 2021 (estimated)
- First posted
- 18 May 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.
Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.
Detailed description
IPL procedure is a device used for symptom relief and treatment of dry eye syndrome caused by meibomian gland dysfunction in adults, and its safety and long-term effects have been confirmed. The purpose of this study is to determine whether this procedure before cataract surgery is effective in improving the symptoms of dry eye syndrome after cataract surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPL group | Active comparator | Procedure: IPLSubject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery |
| Non-IPL group | No intervention | –Subject who do not have intense pulsed light (IPL) laser before 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)
- A patient at the age of 21 cataract surgery
- A patient has the visual potential of 20/25 or better in each eye after cataract removal
- Dry eye patient by meibomian gland dysfunction
- Written informed consent to surgery and participation in the study
Key exclusion criteria (11 listed)
- Eye damage, active eye infection
- Uncontrolled health problem
- Wear contact lens within one month
- Allergic reactions of fluorescein sodium or ophtalmic anesthetic
- Eye surgery and trauma in the last six 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 |
|---|---|---|
| IPLIntense pulse light (IPL) laser is used for the treatment of dry eye originated from meibomian gland dysfunction. IPL laser will be performed to patients who are planned to cataract surgery to improve dry eye. | Procedure or surgery | IPL group |
Primary outcome
TBUT
Time frame: 3 months
tear break-up time
meibomian gland function score
Time frame: 3 months
By expression of eyelid, scoring of expressibility and quality of meibum will be tested. Form of secretion predominantly secreted by the eight meibomian glands in the center of the lid was evaluated as follows. grade 0, clear meibum is easily expressed; grade 1, cloudy meibum is expressed with mild pressure; grade 2, cloudy meibum is expressed with more than moderate pressure; and grade 3, meibum cannot be expressed even with the hard pressure. Higher score means a worst outcome.
2 secondary outcomes
OSDI
Time frame: 3 months
Corneal staining score
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
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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.
Tae-Young Chung, PhD study chair
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IPL in people with Dry Eye Syndromes, 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 11 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: withdrawn, as of the sponsor's last update on 13 May 2022. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
TBUT (time frame: 3 months). The study lists 2 primary outcomes in all. 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 13 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.