The Effect of Cyclosporin Before Cataract Surgery

NCT04426240 | Completed Phase 4

• 1 other identifier: 2019-11-203
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dry Eye Syndromes

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• tear break-up time

  1 month

• Schirmer test

  1 montn

Study Arms (2)

Cyclosporine

ACTIVE COMPARATOR

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

Drug: Cyclosporine microemulsion

non-Cyclosporine

NO INTERVENTION

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

Interventions

Cyclosporine microemulsion DRUG

Intervention group receives topical cyclosporine dry eye treatment before cataract surgery

Also known as: Cyporin

Cyclosporine

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Dry Eye Syndromes

Condition Hierarchy (Ancestors)

Lacrimal Apparatus Diseases; Eye Diseases

Study Officials

• Tae-Young Chung

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 8, 2020
• First Posted: June 11, 2020
• Study Start: August 3, 2020
• Primary Completion: January 26, 2022
• Study Completion: April 19, 2022
• Last Updated: May 13, 2022

Record last verified: 2022-05

Locations

KR (1)