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

• Conditions: Myopia
• Interventions: Device: Orthokeratology lenses

• Registration Number: NCT04275635
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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

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 Timeline

• Study First Submitted: 2020-02-17
• Study First Submitted QC: 2020-02-17
• Study First Posted: 2020-02-19
• Study Start: 2020-02-25
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-12
• Last Update Posted: 2020-03-16
• Primary Completion: 2021-03
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 3000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Children with myopia	Orthokeratology lenses	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.

Primary Outcome Measures

Name	Time	Method
AUROC of the prediction algorithm for identifying fast progressing myopes	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 Outcome Measures

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

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China