The Effect of Wearing Orthokeratology on Objective Visual Quality

Sponsor
XiaoYong Liu (Other)
Overall Status
Recruiting
CT.gov ID
NCT04929119
Collaborator
(none)
30
1
12.8
2.3

Study Details

Study Description

Brief Summary

The visual quality indexes of these patients before and after Orthokeratology treatment were compared: 4 mm higher strehl ratio (SR) , 4 mm higher order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Comas, Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    USING OPD-SCAN III instrument method: Drag The joystick to focus on the screen prompt, and the device automatically starts to measure the aberration when the yellow focus is shown; Simk will change from black to rose red when the aberration is measured to start measuring the corneal topography, prompting the patient to blink the tear film evenly and press the button on the joystick when the focus is completed.The following data were obtained and analyzed: 4 mm high order STREHL rate (SR) , 4 mm high order corneal aberration (Hoa ) , Spherical Aberration (SA) , Coma Aberration (Coma) , Trefoil Aberration (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    30 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    The Effect of Wearing Orthokeratology on Objective Visual Quality
    Actual Study Start Date :
    Mar 7, 2021
    Anticipated Primary Completion Date :
    Mar 31, 2022
    Anticipated Study Completion Date :
    Mar 31, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    Before wearing the Orthokeratology

    OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Wear Orthokeratology for a week

    OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Wear Orthokeratology for a month

    OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Wear Orthokeratology for three months

    OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Wear Orthokeratology for six months

    OPD-Scan was performed and the following data were recorded: 4 mm high order strehl ratio (SR) , 4 mm high order corneal aberrations (Hoa ) , Spherical Aberrations (SA) , Coma Aberrations (Coma) , Trefoil Aberrations (RMS) , corneal aspheric index (Q, e) , corneal surface regularity index (SRI) , corneal surface asymmetry index (Sai)

    Outcome Measures

    Primary Outcome Measures

    1. 4 mm high-order strehl ratio [6 months]

      Objective visual quality 1

    2. 4 mm high-order corneal aberrations (Hoa) in Microns [6 months]

      Objective visual quality 2

    3. Spherical Aberrations (SA) in Microns [6 months]

      Objective visual quality 3

    4. Coma Aberrations (COMA) in Microns [6 months]

      Objective visual quality 4

    5. Trefoil Aberrations in Microns [6 months]

      Objective visual quality 5

    6. corneal aspheric index(Q) [6 months]

      Objective visual quality 6

    7. corneal aspheric index(e) [6 months]

      Objective visual quality 7

    8. corneal surface regularity index (SRI) [6 months]

      Objective visual quality 8

    9. corneal surface asymmetry index (Sai) [6 months]

      Objective visual quality 9

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • The subject understands the purpose of this clinical trial and is willing, able and committed to return to the center for all clinical trial visits and to complete all research related procedures
    Exclusion Criteria:
      1. Associated with corneal abnormalities, such as active Keratitis (corneal infection) , corneal dystrophy, Keratoconus, corneal Leukoplakia, corneal hypoesthesia, or previous corneal surgery, or a history of corneal trauma;
    • 2, there are other eye diseases, such as Dacryocystitis, dry eye disease, conjunctivitis, blepharitis, Uveitis, and other inflammation, Glaucoma, cataracts, fundus disease, eye tumors, ocular trauma, squint patients;

      1. A history of allergy to contact lens or contact Lens Solution.
      1. Test results indicate that subjects with contraindications or unsuitable for wearing Orthokeratology.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 First Affiliated Hospital of Jinan University Guangdong Guangzhou China 510632

    Sponsors and Collaborators

    • XiaoYong Liu

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    XiaoYong Liu, Deputy chief physician, First Affiliated Hospital of Jinan University
    ClinicalTrials.gov Identifier:
    NCT04929119
    Other Study ID Numbers:
    • 2021jnU
    First Posted:
    Jun 18, 2021
    Last Update Posted:
    Jun 18, 2021
    Last Verified:
    Jun 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by XiaoYong Liu, Deputy chief physician, First Affiliated Hospital of Jinan University

    Study Results

    No Results Posted as of Jun 18, 2021