Study Stopped
Due to the covid 19, patient recruiment is not going smoothly, so the study was canceled.
Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Mar 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 3, 2020
CompletedFirst Submitted
Initial submission to the registry
May 15, 2020
CompletedFirst Posted
Study publicly available on registry
May 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2021
CompletedMay 13, 2022
May 1, 2022
12 months
May 15, 2020
May 9, 2022
Conditions
Outcome Measures
Primary Outcomes (2)
TBUT
tear break-up time
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.
3 months
Secondary Outcomes (2)
OSDI
3 months
Corneal staining score
3 months
Study Arms (2)
IPL group
ACTIVE COMPARATORSubject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery
Non-IPL group
NO INTERVENTIONSubject who do not have intense pulsed light (IPL) laser before cataract surgery
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Samsung Medical Center
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tae-Young Chung, PhD
Samsung Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 15, 2020
First Posted
May 18, 2020
Study Start
March 3, 2020
Primary Completion
March 2, 2021
Study Completion
March 2, 2021
Last Updated
May 13, 2022
Record last verified: 2022-05