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A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group)

Status Approved

  • First Submitted Date

    2018/05/31

  • Registered Date

    2019/04/11

  • Last Updated Date

    2019/04/01

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
    KCT0003743
    Unique Protocol ID KYUH 2017-12-012
    Public/Brief Title A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group)
    Scientific Title A Study on Healthy Eye Reference Database of Koreans using Spectral Domain OCT.(Prospective, Single Institution, Public, Intervention, Single Group)
    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 KYUH 2017-12-012-001
    Approval Date 2018-02-06
    Institutional Review Board Name KONYANG UNIV.HOSPITAL IRB
    Institutional Review Board Address 158, Gwanjeodong-ro, Seo-gu, Daejeon
    Institutional Review Board Telephone 042-600-9057
    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 JEONG JAE HOON
    Title MD,PhD
    Telephone +82-42-600-9250
    Affiliation Konyang University Hospital
    Address 158, Gwanjeodong-ro, Seo-gu, Daejeon, Republic of Korea
    Contact Person for Public Queries
    Name JEONG JAE HOON
    Title MD,PhD
    Telephone +82-42-600-9250
    Affiliation Konyang University Hospital
    Address 158, Gwanjeodong-ro, Seo-gu, Daejeon, Republic of Korea
    Contact Person for Updating Information
    Name LEE CHANG SOO
    Title QM Manager
    Telephone +82-31-428-9151
    Affiliation Huvitz
    Address 38, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055, Republic of 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 Recruiting
    Date of First Enrollment 2018-03-07 Actual
    Target Number of Participant 200
    Primary Completion Date 2018-10-19 , Actual
    Study Completion Date 2019-04-30 , Anticipated
    Recruitment Status by Participating Study Site 1
    Name of Study Konyang University Hospital
    Recruitment Status Recruiting
    Date of First Enrollment 2018-03-07 ,
  • 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 Huvitz
    Organization Type Others
    Project ID
  • 6. Sponsor Organization

    Sponsor Organization Information - Organization Name, Organization Type
    1. Sponsor Organization
    Organization Name Huvitz
    Organization Type Others
  • 7. Study Summary

    Study Summary Information
    Lay Summary
    OCT(Optical Coherence Tomography) is known as an effective device that provides necessary information to detect Glaucoma and Retinal disease in early phase. And OCT Reference Database collected in healthy eyes should be established to suggest in which level the patient’s results are compared to the normal eyes.
    In this study, establish the reference database of 300 health eyes after pre-defined screening test.
  • 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
    Others
    (Data gathering)
    Phase Not applicable
    Intervention Model Single Group  
    Blinding/Masking Open
    Allocation Not Applicable
    Intervention Type Medical Device  
    Intervention Description
    according to the pre-defined screenning test, measure the healthy eye 3times.
    Number of Arms 1
    Arm 1

    Arm Label

    Healthy eye

    Target Number of Participant

    200

    Arm Type

    Experimental

    Arm Description

    1. average, superior, inferior, terporal and nasal thickness of retinal nerve fiber layer.
    2. thickness of O'clock hour segement in retinal nerve fiber layer.
    3. thickness of central fovea, inner macular and outer macular.
  • 9. Subject Eligibility

    Subject Eligibility Information
    Condition(s)/Problem(s) * (H00-H59)Diseases of the eye and adnexa 
       (H40.9)Glaucoma, unspecified 

    healthy eye.
    Rare Disease No
    Inclusion Criteria

    Gender

    Both

    Age

    20Year~70Year

    Description

    1. Age range between more than 20 ~ less than 70 years old.
    2. Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent
    3. No ocular medication (except artificial tears/moistening drops) necessary
    4. Eyes with spherical power <= ±4.0D, cylindrical power <= ±3.0D
    5. Corrected distance visual acuity
    - ≥ 1.0 [20/20] for subjects up to 60 years;
    - ≥ 0.8 [20/25] for subjects from 61 to 70 years; 
    6. Intraocular pressure <= 21 mmHg
    7. Normal anterior segments, i.e. no clinically-relevant abnormalities
    -. Eyes with no closed iridocorneal angle structure
    8. Ocular fundus: normal appearance, i.e. no clinically-relevant abnormalities (examination with undilated pupils)
    9. Eyes without prior intraocular surgery (except cataract surgery) without clinically-relevant vitreal, retinal or choroidal diseases, diabetic retinopathy, or disease of the optic nerve.
    10. Eyes without a history of corneal refractive surgery.
    Exclusion Criteria
    1. Amblyopia
    2. Relevant opacities of the central refractive media (cornea, lens, vitreous body)
    3.Drugs indicating severe general diseases (anti-diabetic pharmaceuticals
     and anti-hypertensive medication are allowed for subjects older than 70 years)
    4. Eyes having experience wearing hard contact(RGB) lenses within 2 weeks from the screening date
    5. Pregnant or lactating women
    6. One who can influence the study results by ethically or else, accordingly considered to be ineligible
    Healthy Volunteers Yes
  • 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
    Pearson correlation coefficient between age and thickness, RNFL thickness with segmentation.
    Timepoint
    same time
    Secondary Outcome(s) 1
    Outcome
    O’clock hour segment thickness of RNFL
    Timepoint
    same time
    Secondary Outcome(s) 2
    Outcome
    Macular thickness
    Timepoint
    same time
    Secondary Outcome(s) 3
    Outcome
    Optic nerve head parameter area or ratio
    Timepoint
    same time
  • 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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