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

N/AWithdrawnNCT04391907

Samsung Medical Center

Overview

Clinical efficacy of Intense Pulsed Light(IPL) procedure in dry eye patients with meibomian gland dysfunction prior to cataract surgery.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Conditions

Dry Eye Syndromes

Interventions

IPLPROCEDURE

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

Sex: ALLMin age: 21 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Samsung Medical Center

Seoul, South Korea

Outcomes

Primary Outcomes

TBUT

tear break-up time

Time frame: 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.

Time frame: 3 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 3 months

Data from ClinicalTrials.gov

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