The Effect of Cyclosporin Before Cataract Surgery

NCT ID: NCT04426240

Last Updated: 2022-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-08-03

Study Completion Date

2022-04-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dry Eye Syndromes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cyclosporine

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

Group Type ACTIVE_COMPARATOR

Cyclosporine microemulsion

Intervention Type DRUG

Intervention group receives topical cyclosporine dry eye treatment before cataract surgery

non-Cyclosporine

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cyclosporine microemulsion

Intervention group receives topical cyclosporine dry eye treatment before cataract surgery

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Cyporin

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Samsung Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

tae-young chung

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tae-Young Chung

Role: PRINCIPAL_INVESTIGATOR

Samsung Medical Center

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Samsung Medical Center

Seoul, , South Korea

Site Status

Countries

Review the countries where the study has at least one active or historical site.

South Korea

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019-11-203

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Effect of Artificial Tears on Biometry
NCT04230720 WITHDRAWN PHASE4