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Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patient

Clinical Efficacy of Intense Pulsed Light(IPL) Procedure in Dry Eye Patients With Meibomian Gland Dysfunction Prior to Cataract Surgery

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04391907
Enrollment
0
Registered
2020-05-18
Start date
2020-03-03
Completion date
2021-03-02
Last updated
2022-05-13

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

Conditions

Dry Eye Syndromes

Brief summary

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.

Interventions

PROCEDUREIPL

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.

Sponsors

Samsung Medical Center
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

1. A patient at the age of 21 cataract surgery 2. A patient has the visual potential of 20/25 or better in each eye after cataract removal 3. Dry eye patient by meibomian gland dysfunction 4. Written informed consent to surgery and participation in the study

Exclusion criteria

1. Eye damage, active eye infection 2. Uncontrolled health problem 3. Wear contact lens within one month 4. Allergic reactions of fluorescein sodium or ophtalmic anesthetic 5. Eye surgery and trauma in the last six months 6. Eye disease, structural abnormality 7. If there is a cause of vision loss other than cataracts 8. Under 20/25 expect vision 9. Under the age of 20 years of age 10. Pregnant woman and lactating woman 11. Medical conditions in which IPL is contraindicated

Design outcomes

Primary

MeasureTime frameDescription
TBUT3 monthstear break-up time
meibomian gland function score3 monthsBy 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.

Secondary

MeasureTime frameDescription
OSDI3 monthsquestionnaire 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.
Corneal staining score3 monthsPunctate 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.

Countries

South Korea

Outcome results

None listed

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