The Effect of Cyclosporin Before Cataract Surgery

Samsung Medical Center

Status and phase: Completed; Phase 4

Conditions: Dry Eye Syndromes

Treatments: Drug: Cyclosporine microemulsion

Study type: Interventional

Funder types: Other

Identifiers

NCT04426240

2019-11-203

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

Cyclosporine

Active Comparator group

Description:

Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery

Treatment:

Drug: Cyclosporine microemulsion

non-Cyclosporine

No Intervention group

Description:

Subject who use only hyaluronate eye drop 1 month before cataract surgery