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

• Conditions: Myopia
• Interventions: Device: Orthokeratology lenses

• Registration Number: NCT04284111
• Lead Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Brief Summary

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.

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 Timeline

• Status Verified: 2020-02
• Study First Submitted: 2020-02-21
• Study First Submitted QC: 2020-02-21
• Study First Posted: 2020-02-25
• Study Start: 2020-02-26
• Last Update Submitted: 2020-02-26
• Last Update Posted: 2020-02-28
• Primary Completion: 2021-03
• Study Completion: 2021-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

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 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.

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.
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.
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.

Trial Locations

Locations (8)

Nanchang Bright Eye Hospital; 🇨🇳 Nanchang, Jiangxi, China

Jinan Bright Eye Hospital; 🇨🇳 Jinan, Shandong, China

Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China

Hefei Bright Eye Hospital; 🇨🇳 Hefei, Anhui, China

Wuhan Bright Eye hospital; 🇨🇳 Wuhan, Hubei, China

Shanghai Bright Eye Hospital; 🇨🇳 Shanghai, Shanghai Province, China

Chengdu Bright Eye Hospital; 🇨🇳 Chengdu, Sichuan, China

Kunming Bright Eye hospital; 🇨🇳 Kunming, Yunnan, China