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

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

Detailed Description
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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.

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

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Procedure: IPL


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: IPL group<br>Subject who have intense pulsed light (IPL) laser 2 twice 1-6 weeks before cataract surgery | Procedure: IPL<br>* 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.<br>|
| No Intervention: Non-IPL group<br>Subject who do not have intense pulsed light (IPL) laser before cataract surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 3 months |