The Effect of Cyclosporin Before Cataract Surgery

Dry Eye Syndromes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04426240
• Other study ID #: 2019-11-203
• Status: Completed
• Phase: Phase 4
• Start date: August 3, 2020
• Est. completion date: April 19, 2022

Study information

• Verified date: May 2022
• Source: Samsung Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: April 19, 2022
• Est. primary completion date: January 26, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract
• Dry Eye Syndromes
• Keratoconjunctivitis Sicca

Intervention

Drug:
• Cyclosporine microemulsion
Intervention group receives topical cyclosporine dry eye treatment before cataract surgery

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Samsung Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	tear break-up time	Time to break tear film	1 month
Secondary	Schirmer test	Tear secretion test	1 montn