The Effect of Cyclosporin Before Cataract Surgery

Study Overview
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Brief Summary
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To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.

Official Title
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A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye

Conditions
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Dry Eye Syndromes

Intervention / Treatment
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* Drug: Cyclosporine microemulsion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 21+ adult men and women Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract Corneal fluorescein staining score (Oxford) is II or less Preoperative MMP-9 positive Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery. Those who have voluntarily written consent to participate in this clinical trial Exclusion Criteria Those who have used systemic or topical cyclosporine within 4 weeks Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial. Abnormal eyelid function An eye disease that can impair the function of the corneal sensation: herpes keratopathy, conjunctival wounds due to scarring conjunctivitis, pterygium, pinguecula, diabetic keratitis, keratoconus , corneal transplant status Patients with active eye infections Patients with conflicts with this clinical trial Pregnant and lactating mothers Patients who are determined to be inappropriate by other investigators

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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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclosporine<br>Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery | Drug: Cyclosporine microemulsion<br>* Intervention group receives topical cyclosporine dry eye treatment before cataract surgery<br>* Other names: Cyporin;|
| No Intervention: non-Cyclosporine<br>Subject who use only hyaluronate eye drop 1 month before cataract surgery | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal florescence staining score | Standardized corneal staining score (NEI score, National eye institute score) : dividing the cornea into five sections and assigning 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear break-up time | Time to break tear film | 1 month | 
| Schirmer test | Tear secretion test | 1 montn |