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OpenTrials
Completed

NCT Number: NCT04426240

The Effect of Cyclosporin Before Cataract Surgery

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

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Key information

Conditions

Dry Eye Syndromes Eye Diseases Lacrimal Apparatus Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Samsung Medical Center

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 21+ 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

Exclusion criteria

  • 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

Treatment and study plan

Cyclosporine microemulsion

Drug

Intervention group receives topical cyclosporine dry eye treatment before cataract surgery

Other names: Cyporin

Primary outcomes

  1. Corneal florescence staining score

    Time frame: 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 outcomes

  1. tear break-up time

    Time frame: 1 month

    Time to break tear film

  2. Schirmer test

    Time frame: 1 montn

    Tear secretion test

Sponsors and collaborators

Lead sponsor

Samsung Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 11, 2020
Registry last updated
May 13, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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