Validation of a Predictive Algorithm to Determine the Effectiveness of Orthokeratology for Myopia Control

This is a prospective study to validate a predictive algorithm for identifying fast progressing myopes.

Study Overview

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

Detailed Description

Orthokeratology (ortho-K) has been demonstrated to slow myopic progression and reduce axial elongation in young patients, but this treatment is limited by the need for contact lens wear, which is the common cause for keratitis in children, and therefore cautious use is recommended. There is a need to identify the patients that could benefit most from this treatment. In order to do so, we conduct a retrospective study and create a large database (n = 10,000) of de-identified data to train an algorithm for identifying fast progressing myopes. In addition, we will perform a prospective study to validate this predictive algorithm and determine the effectiveness of Orthokeratology among different individual patients in China.

• Study Type: Observational
• Enrollment (Anticipated): 3000

Contacts and Locations

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510000
      • Recruiting
      • Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University

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

3,000 children from Zhongshan Ophthalmic Center 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 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K.	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: 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 25, 2020
• Primary Completion (ANTICIPATED): March 1, 2021
• Study Completion (ANTICIPATED): August 1, 2021

Study Registration Dates

• First Submitted: February 17, 2020
• First Submitted That Met QC Criteria: February 17, 2020
• First Posted (ACTUAL): February 19, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 16, 2020
• Last Update Submitted That Met QC Criteria: March 12, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2020KYPJ018

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