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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04284111
• Other study ID #: 2020KYPJ019
• Status: Recruiting
• Start date: February 26, 2020
• Est. completion date: August 2021

Study information

• Verified date: February 2020
• Source: Zhongshan Ophthalmic Center, Sun Yat-sen University
• Contact: Xialin Liu, M.D. Ph.D.
• Phone: +8613719109851
• Email: liuxialin[@]gzzoc.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: August 2021
• Est. primary completion date: March 2021
• Gender: All
• Age group: 8 Years to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• Orthokeratology lenses
Orthokeratology lenses

Locations

Country	Name	City	State
China	Chengdu Bright Eye Hospital	Chengdu	Sichuan
China	Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University	Guangzhou	Guangdong
China	Hefei Bright Eye Hospital	Hefei	Anhui
China	Jinan Bright Eye Hospital	Jinan	Shandong
China	Kunming Bright Eye hospital	Kunming	Yunnan
China	Nanchang Bright Eye Hospital	Nanchang	Jiangxi
China	Shanghai Bright Eye Hospital	Shanghai	Shanghai Province
China	Wuhan Bright Eye hospital	Wuhan	Hubei

Sponsors (1)

Lead Sponsor	Collaborator
Zhongshan Ophthalmic Center, Sun Yat-sen University

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Performance of an algorithm for predicting AL	The investigators will use mean absolute error (MAE), R square to evaluate the performance.	1 year
Secondary	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