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The Effect of Cyclosporin Before Cataract Surgery

Primary Purpose

Dry Eye Syndromes

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Cyclosporine microemulsion
Sponsored by
Samsung Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dry Eye Syndromes

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Cyclosporine

non-Cyclosporine

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

tear break-up time
Time to break tear film
Schirmer test
Tear secretion test

Full Information

First Posted
June 8, 2020
Last Updated
May 9, 2022
Sponsor
Samsung Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04426240
Brief Title
The Effect of Cyclosporin Before Cataract Surgery
Official Title
A Comparative Study of Use of Cyclosporin Eye Before Cataract Surgery for the Prevention of Dry Eye
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
August 3, 2020 (Actual)
Primary Completion Date
January 26, 2022 (Actual)
Study Completion Date
April 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Samsung Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dry Eye Syndromes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cyclosporine
Arm Type
Active Comparator
Arm Description
Subject who use cyclosporine and hyaluronate artificial tear 1 month before cataract surgery
Arm Title
non-Cyclosporine
Arm Type
No Intervention
Arm Description
Subject who use only hyaluronate eye drop 1 month before cataract surgery
Intervention Type
Drug
Intervention Name(s)
Cyclosporine microemulsion
Other Intervention Name(s)
Cyporin
Intervention Description
Intervention group receives topical cyclosporine dry eye treatment before cataract surgery
Primary Outcome Measure Information:
Title
Corneal florescence staining score
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
tear break-up time
Description
Time to break tear film
Time Frame
1 month
Title
Schirmer test
Description
Tear secretion test
Time Frame
1 montn

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Young Chung
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Samsung Medical Center
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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The Effect of Cyclosporin Before Cataract Surgery

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