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Relationship between postoperative vaulting and postoperative refractive error

Status Approved

  • First Submitted Date

    2020/11/16

  • Registered Date

    2020/11/24

  • Last Updated Date

    2020/11/16

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
    KCT0005621
    Unique Protocol ID P01-202010-21-024
    Public/Brief Title Clinical results of Visian implantable collamer lens implantation according to various sizes and implantation angles
    Scientific Title Relationship between postoperative vaulting and postoperative refractive error
    Acronym
    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 P01-202010-21-024
    Approval Date 2020-10-19
    Institutional Review Board Name Public Internal Regulatory Board of the Ministry of Health and Welfare, Korea
    Institutional Review Board Address #601, 53, Yulgok-ro, Jongno-gu, Seoul
    Institutional Review Board Telephone 02-737-8995
    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 Bu Ki Kim
    Title Dr.
    Telephone +82-2-6913-0000
    Affiliation Onnuri Smile Ophthalmic Clinic
    Address Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea
    Contact Person for Public Queries
    Name Bu Ki Kim
    Title Dr.
    Telephone +82-2-6913-0000
    Affiliation Onnuri Smile Ophthalmic Clinic
    Address Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea
    Contact Person for Updating Information
    Name Bu Ki Kim
    Title Dr.
    Telephone +82-2-6913-0000
    Affiliation Onnuri Smile Ophthalmic Clinic
    Address Hyobong Building 9F 1, Gangnam-daero 65 gil, Seocho-gu, Seoul, Korea
  • 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 Completed
    Date of First Enrollment 2020-10-20 Actual
    Target Number of Participant 300
    Primary Completion Date
    Study Completion Date
    Recruitment Status by Participating Study Site 1
    Name of Study Onnuri Smile Ophthalmic Clinic
    Recruitment Status Completed
    Date of First Enrollment 2020-10-20 ,
  • 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 Onnuri Smile Ophthalmic Clinic
    Organization Type Medical Institute
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Onnuri Smile Ophthalmic Clinic
    Organization Type Medical Institute
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    Successful ICL implantation is related to ICL vault, defined as the distance between the anterior surface of the crystalline lens and the posterior surface of the ICL. Achieving an appropriate ICL vault is critical for preventing major postoperative adverse events.General consensus of ideal vault is 0.25 to 0.75 mm, however there are no exact criteria for surgical correction of the vault in the absence of vault-related complications, as there are also risks of repeated surgery such as corneal endothelial damage or astigmatic increase. So changing surgical plan of the fellow eye for achieving ideal vault according to the vault of first operated eye can be a good alternative method. But to our best knowledge, clinical outcomes about different size of ICL or different implantation angle of ICL on both eyes has not yet been reported. the aim of this study is to investigate effect of clinical outcomes when different size or different implantation angle of ICL was used for both eyes, and we also evaluated relationship between postoperative vault and refractive errors.
  • 8. Study Design

    Study Design Information - Study Type, Observational Study Model, Time Perspective, Target Number of Participant, Cohort/Group Number, Cohort/Group, Cohort/Group Label, Cohort/Group Description, Biospecimen Collection & Archiving, Biospecimen Description
    Study Type Observational Study
    Observational Study Model Case-control
    Time Perspective Retrospective  
    Target Number of Participant 300
    Cohort/Group Number 3
    Cohort/
    Group 1

    Cohort/Group Label

    Same sized-ICL implanted horizontally on both eyes

    Cohort/Group Description

    Same sized-ICL implanted horizontally on both eyes
    Cohort/
    Group 2

    Cohort/Group Label

    Different size of ICL implanted horizontally on both eyes

    Cohort/Group Description

    One size larger or smaller ICL was implanted horizontally, based on postoperative vault of initially operated eye.
    Cohort/
    Group 3

    Cohort/Group Label

    Same sized-ICL implanted with different implantation angle on both eyes

    Cohort/Group Description

    one eye - 90 degree, the other eye - 180 degree angle was used.
    Biospecimen
    Collection & Archiving
    Not collect nor Archive
    Biospecimen Description
  • 9. Subject Eligibility

    Subject Eligibility Information
    Study Population Description
    Patients who visited our clinic for refractive surgery and the cornea is thin or has high refractive power before surgery
    Sampling Method
    convenience sampling
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H52.1)Myopia 

    Myopia
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    19Year~50Year

    Description

    corrected distance visual acuity ≥ 20/40, ACD > 2.8 mm, stable bilateral myopia for at least 1 years, refractive error in the correctable range (from -0.50 to -18.00 diopters), endothelial cell density ≥ 2,000 cells/mm2, and difference in horizontal WTW on both eye < 0.2 mm.
    Exclusion Criteria
    history of previous ocular surgery or trauma, uncontrolled systemic disease, corneal scarring or vascularization, and pregnancy
    Healthy Volunteers
  • 10. Outcome Measure(s)

    Outcome Measure(s) Information - Type of Primary Outcome, Primary Outcome, Outcome, Timepoint, Secondary Outcome, Outcome, Timepoint
    Type of Primary Outcome /Safety/Efficacy
    Primary Outcome(s) 1
    Outcome
    Postoperative vault
    Timepoint
    1 day, 1 month, 3 months, 6 months, 12 months
    Secondary Outcome(s) 1
    Outcome
    Postoperative spherical equivalent
    Timepoint
    1 day, 1 month, 3 months, 6 months, 12 months
    Secondary Outcome(s) 2
    Outcome
    Postoperative intraocular pressure
    Timepoint
    1 day, 1 month, 3 months, 6 months, 12 months
    Secondary Outcome(s) 3
    Outcome
    Postoperative endothelial cell density
    Timepoint
    1 day, 1 month, 3 months, 6 months, 12 months
    Secondary Outcome(s) 4
    Outcome
    Postoperative uncorrected distance visual acuity
    Timepoint
    1 day, 1 month, 3 months, 6 months, 12 months
  • 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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