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Effect of Preoperative Eyedrops on Cytokine Concentrations in Aqueous Humor of Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery

Status Approved

  • First Submitted Date

    2020/12/14

  • Registered Date

    2020/12/29

  • Last Updated Date

    2020/12/14

CRIS Required

WHO ICTRP (International Clinical Trial Registry Platform) Required

  • 1. Background

    Background - CRIS Registration Number, Unique Protocol ID, Public/Brief Title, Scientific Title, Acronym, MFDS Regulated Study, IND/IDE Protocol, Registered at Other Registry, Name of Registry/Registration Number
    CRIS
    Registration Number
    KCT0005717
    Unique Protocol ID 2020-0056
    Public/Brief Title inflammation and medication in femtosecond laser-assisted cataract surgery
    Scientific Title Effect of Preoperative Eyedrops on Cytokine Concentrations in Aqueous Humor of Patients Undergoing Femtosecond Laser-Assisted Cataract Surgery
    Acronym anti-inflammatory eyedrops for femtosecond laser-assisted cataract surgery
    MFDS Regulated Study No
    IND/IDE Protocol No
    Registered at Other Registry No
    Healthcare Benefit Approval Status Not applicable
  • 2. Institutional Review Board / Ethics Committee

    Institutional Review Board Information
    Board Approval Status Submitted approval
    Board Approval Number 2020-0056
    Approval Date 2020-01-17
    Institutional Review Board Name Institutional Review Board of the Asan Medical Center and the University of Ulsan College of Medicine
    Institutional Review Board Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Institutional Review Board Telephone 02-3010-7166
    Data Monitoring Committee No
  • 3. Contact Details

    Contact Details Information - Contact Person for Principal Investigator / Scientific Queries, Contact Person for Public Queries, Contact Person for Updating Information의 Name, Title, Email, Telephone, Cellular Phone, Affiliation, Address
    Contact Person for Principal Investigator / Scientific Queries
    Name Hungwon Tchah
    Title Dr
    Telephone +82-2-3010-3680
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Contact Person for Public Queries
    Name Hungwon Tchah
    Title Dr
    Telephone +82-2-3010-3680
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
    Contact Person for Updating Information
    Name Hungwon Tchah
    Title Dr
    Telephone +82-2-3010-3680
    Affiliation Asan Medical Center
    Address 88, Olympic-ro 43-gil, Songpa-gu, Seoul
  • 4. Status

    Status Information - Study Site, Overall Recruitment Status, Date of First Enrollment, Status of First Enrollment, Target Number of Participant, Primary Completion Date, Recruitment Status by Participating Study Site, Name of Study Site, Recruitment Status, Date of First Enrollment, Status of First Enrollemnt
    Study Site Single
    Overall Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-01-17 Actual
    Target Number of Participant 120
    Primary Completion Date 2021-12-31 , Anticipated
    Study Completion Date 2021-12-31 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Asan Medical Center
    Recruitment Status Active, not recruiting
    Date of First Enrollment 2020-01-17 ,
  • 5. Source of Monetary / Material Support

    Source of Monetary / Material Support Information - Organization Name, Organization Type, Project ID
    1. Source of Monetary/Material Support
    Organization Name Asan Medical Center
    Organization Type Medical Institute
    Project ID 2020-0056
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Asan Medical Center
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    The number of patients undergoing femtosecond laser-assiated cataract surgery is increasing, however, the intraocular effects of it have not been sufficiently evaluated. The purpose of this study was to compare the anti-inflammatory activity of preoperatively applied eyedrops, as determined by cytokine concentrations in aqueous humor collected during surgery in patients undergoing femtosecond laser-assisted cataract surgery.
  • 8. Study Design

    Study Design Information - Study Type, Study Purpose, Phase, Intervention Model, Blinding/Masking, Blinded Subject, Allocation, Intervention Type, Intervention Description, Number of Arms, Arm Label, Target Number of Participant, Arm Type, Arm Description
    Study Type Interventional Study
    Study Purpose
    Treatment
    Phase Not applicable
    Intervention Model Parallel  
    Blinding/Masking Open
    Allocation RCT
    Intervention Type Drug  
    Intervention Description
    A total of 120 patients undergoing femtosecond laser-assisted cataract surgery were randomly assigned to four groups of 30 patients each who were administered no eyedrops, fluorometholone 0.1% (Flumetholone®) eyedrops, ketorolac tromethamine 0.45% (ACUVAIL®) eyedrops, and both 0.1% fluorometholone and 0.45% ketorolac tromethamine. Eyedrops were instilled 1 hour, 20 minutes, and just before surgery. After femtosecond laser surgery, a corneal incision of about 1 mm was made in the 2 o'clock position, and about 0.1 cc aqueous humor was obtained using a 1 cc syringe and a 26-gauge needle. Cytokine and PGE2 concentrations were quantitatively determined.
    Number of Arms 4
    Arm 1

    Arm Label

    control group

    Target Number of Participant

    30

    Arm Type

    No intervention

    Arm Description

    the group who were administered no eyedrops
    Arm 2

    Arm Label

    steroid group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    the group who were administered a drop of Fluorometholone 0.1% (Flumetholone®) eyedrops three times preoperatively
    Arm 3

    Arm Label

    NSAID group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    the group who were administered a drop of Ketorolac tromethamine 0.45% (Acuvail®) eyedrops three times preoperatively
    Arm 4

    Arm Label

    steroid plus NSAID group

    Target Number of Participant

    30

    Arm Type

    Experimental

    Arm Description

    the group who were administered both a drop of Fluorometholone 0.1% (Flumetholone®) and Ketorolac tromethamine 0.45% (Acuvail®) eyedrops three times preoperatively
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H26.99)Cataract, unspecified, unspecified side 

    cataract
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    21Year~80Year

    Description

    patients with uncomplicated senile cataract undergoing unilateral femtosecond laser-assited cataract surgery
    Exclusion Criteria
    patients with history of ocular surgery or trauma, corneal opacity, retinopathy, glaucoma, uveitis, amblyopia or complication including intraoperative posterior capsule rupture
    Healthy Volunteers No
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome Efficacy
    Primary Outcome(s) 1
    Outcome
    IL-6 concentration in aqueous humor
    Timepoint
    right after the femtosecond laser
    Primary Outcome(s) 2
    Outcome
    IL-8 concentration in aqueous humor
    Timepoint
    right after the femtosecond laser
    Primary Outcome(s) 3
    Outcome
    TNF-α concentration in aqueous humor
    Timepoint
    right after the femtosecond laser
    Primary Outcome(s) 4
    Outcome
    PGE2 concentration in aqueous humor
    Timepoint
    right after the femtosecond laser
    Secondary Outcome(s) 1
    Outcome
    age
    Timepoint
    enroll
    Secondary Outcome(s) 2
    Outcome
    gender
    Timepoint
    enroll
    Secondary Outcome(s) 3
    Outcome
    Eye laterality
    Timepoint
    enroll
  • 11. Study Results and Publication

    Study Results and Publication Information - Result Registered, Final Enrollment Number, Number of Publication, Publications, Results Upload, Date of Posting Results, Protocol URL or File Upload, Brief Summary
    Result Registered No
  • 12. Sharing of Study Data(Deidentified Individual-Patient Data, IPD)

    Sharing of Study Data Information - Sharing Statement, Time of Sharing, Way of Sharing
    Sharing Statement No
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