Dry Eye Syndromes
Conditions
Brief summary
To evaluate the effect of cyclosporine eye drop before cataract surgery for the prevention of post cataract surgery dry eye syndrome.
Interventions
Intervention group receives topical cyclosporine dry eye treatment before cataract surgery
Sponsors
Samsung Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 21+ adult men and women 2. Those who are scheduled to undergo cataract surgery due to a diagnosis of cataract 3. Corneal fluorescein staining score (Oxford) is II or less 4. Preoperative MMP-9 positive 5. Those who have not used the trial and the test (cyclosporine) for at least 1 month before surgery. 6. Those who have voluntarily written consent to participate in this clinical trial
Exclusion criteria
1. Those who have used systemic or topical cyclosporine within 4 weeks 2. Use of eye drops for more than 4 weeks (disorders, allergies, eye inflammation / infection, etc.) other than the current dry eye syndromes 3. Patients who have systemic or ocular disorders or conditions (eye surgery, trauma, disease) that can influence the results of this trial. 4. Abnormal eyelid function 5. 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 6. Patients with active eye infections 7. Patients with conflicts with this clinical trial 8. Pregnant and lactating mothers 9. Patients who are determined to be inappropriate by other investigators
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Corneal florescence staining score | 1 month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| tear break-up time | 1 month | Time to break tear film |
| Schirmer test | 1 montn | Tear secretion test |
Countries
South Korea
Outcome results
None listed