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Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology

Sponsor
Tianjin Eye Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT05635526
Collaborator
(none)
134
Enrollment
1
Location
28
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The present research focused on the effect of the age for the corneal biomechanics of low and moderate myopia patients after wearing orthokeratology (OK lens). According to age, the included cases were divided into 3 groups: Ⅰ (8-12 years old), Ⅱ (13-16 years old), Ⅲ (over 16 years old). The OK lenses used in the present study are of the same design (Euclid Systems Orthokeratology; Euclid System, Herndon, VA, USA). The base line (Day 0) and different follow-up time point (Day 1, Week 1, Week 2, Month 1, Month 3, and Month 6) of dynamic corneal response (DCR) (including 19 items) of the patients derived by Corvis ST were collected. The difference between before and after wearing OK Lens and the changes of parameters among the three groups were both analyzed. And the correlation between axis length (AL) and the 19 parameters also was analyzed. Through the analysis of corneal biomechanical parameters, further learn the influence of OK lens on the patient cornea. It would help ophthalmologist and optometrist find out the potential issue and reach a better control result.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    134 participants
    Observational Model:
    Other
    Time Perspective:
    Retrospective
    Official Title:
    Assessment of Corneal Biomechanics With the Corvis ST in Different Age of Myopia With Orthokeratology
    Actual Study Start Date :
    Jun 1, 2020
    Actual Primary Completion Date :
    Jun 1, 2021
    Actual Study Completion Date :
    Oct 1, 2022

    Arms and Interventions

    Arm Intervention/Treatment
    1

    8-12 years old
    2

    13-16 years old
    3

    over 16 years old

    Outcome Measures

    Primary Outcome Measures

    1. The change of dynamic corneal response (DCR) [The change of baseline and 1 day, 1 week, 2 weeks, 1 month, 3 months, and 6 months]

      The axial length was measured by Corvis ST

    Secondary Outcome Measures

    1. The change of axial length [The change of baseline and 6 months]

      The axial length was measured by AL-scan

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    8 Years to 40 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • age from 8 to 40 years old

    • spherical equivalent(SE) was range from -1.00D to -5.00D

    • conform to the standard of wearing orthokeratology lens

    Exclusion Criteria:

    • ocular diseases and systemic diseases

    • visual acuity was less than 20/20

    • unable to follow visitors on time

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Tiajin Eye Hospital Tianjin Tianjin China

    Sponsors and Collaborators

    • Tianjin Eye Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Tianjin Eye Hospital
    ClinicalTrials.gov Identifier:
    NCT05635526
    Other Study ID Numbers:
    • 2022049
    First Posted:
    Dec 2, 2022
    Last Update Posted:
    Dec 2, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Tianjin Eye Hospital
    Myopia prevention and control
    Orthokeratology
    Dynamic corneal response
    Additional relevant MeSH terms:
    Myopia

    Study Results

    No Results Posted as of Dec 2, 2022