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

A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children

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.

Study Overview

• Status: Unknown
• Conditions: Myopia
• Intervention / Treatment: Device: Orthokeratology lenses

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.

• Study Type: Observational
• Enrollment (Anticipated): 1000

Contacts and Locations

• Study Contact: Name: Xialin Liu, M.D. Ph.D.; Phone Number: +8613719109851; Email: liuxialin@gzzoc.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Recruiting
      • Hefei Bright Eye Hospital
      • Contact: Lijuan Wang, M.D
  • Guangdong
    • Guangzhou, Guangdong, China
      • Recruiting
      • Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University
      • Contact: Xialin Liu, MD.
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Wuhan Bright Eye hospital
      • Contact: Shan Lin, M.D
  • Jiangxi
    • Nanchang, Jiangxi, China
      • Recruiting
      • Nanchang Bright Eye Hospital
      • Contact: Yue Yan, M.D
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • Jinan Bright Eye Hospital
      • Contact: Ping Wang, M.D
  • Shanghai Province
    • Shanghai, Shanghai Province, China
      • Recruiting
      • Shanghai Bright Eye Hospital
      • Contact: Yan Yan, M.D
  • Sichuan
    • Chengdu, Sichuan, China
      • Recruiting
      • Chengdu Bright Eye Hospital
      • Contact: Min Cui, M.D
  • Yunnan
    • Kunming, Yunnan, China
      • Recruiting
      • Kunming Bright Eye hospital
      • Contact: Xianghua Yuan, M.D

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 15 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

1,000 children from 8 hospitals in China plan to wear orthokeratology lenses for myopia control.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Device: Orthokeratology lenses; Orthokeratology lenses

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
AUROC of the prediction algorithm for identifying fast progressing myopes	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.	1 year

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Investigators: Principal Investigator: Xialin Liu, M.D. Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2020
• Primary Completion (Anticipated): March 1, 2021
• Study Completion (Anticipated): August 1, 2021

Study Registration Dates

• First Submitted: February 21, 2020
• First Submitted That Met QC Criteria: February 21, 2020
• First Posted (Actual): February 25, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2020
• Last Update Submitted That Met QC Criteria: February 26, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2020KYPJ019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No