A Multi-center Study of the Effect of Orthokeratology on Myopia Progression

Overview

This is a prospective study to validate an algorithm for predicting the effect of orthokeratology on myopia progression in children from 8 hospitals in China.

Full Title of Study: “A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2021

Detailed Description

Orthokeratology (ortho-K) is thought to be an effective way to control the progression of Myopia in children, but its effectiveness may vary among different individuals. The investigators therefore conducted a prospective, multi-center study to use an algorithm to predict the progression of myopia among Chinese children wearing Orthokeratology lenses.

Interventions

  • Device: Orthokeratology lenses
    • Orthokeratology lenses

Arms, Groups and Cohorts

  • Children with myopia
    • A total of 1,000 children from 8 hospitals in China is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing ortho-k lenses.

Clinical Trial Outcome Measures

Primary Measures

  • AUROC of the prediction algorithm for identifying fast progressing myopes
    • Time Frame: 1 year
    • Age-specific axial length (AL) changes previously described by Wang et al.(IOVS, 52 (11), 7949-53, 2011) are used as cut-off values to determine whether a child is a fast progressor or not. A child whose AL change falls on or above the cut-off value is considered to be a fast progressor.

Secondary Measures

  • Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
    • Time Frame: 1 year
    • The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.
  • Performance of an algorithm for predicting AL
    • Time Frame: 1 year
    • The investigators will use mean absolute error (MAE), R square to evaluate the performance.
  • Performance of an algorithm for predicting spherical equivalent refractive error
    • Time Frame: 1 year
    • The investigators will use mean absolute error (MAE), R square to evaluate the performance.

Participating in This Clinical Trial

Inclusion Criteria

  • -6.0D≤SER≤-0.5D – Astigmatism≤2.0D Exclusion Criteria:

  • Contraindications of wearing Ortho-K. – Diagnosis of strabismus, amblyopia and other refractive development of the eye or systemic diseases. – Currently involved in other clinical studies.

Gender Eligibility: All

Minimum Age: 8 Years

Maximum Age: 15 Years

Investigator Details

  • Lead Sponsor
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Xialin Liu, M.D. Ph.D., Principal Investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Overall Contact(s)
    • Xialin Liu, M.D. Ph.D., +8613719109851, liuxialin@gzzoc.com

References

Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.

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