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

Myopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04275635
• Other study ID #: 2020KYPJ018
• Status: Recruiting
• Start date: February 25, 2020
• Est. completion date: August 2021

Study information

• Verified date: March 2020
• Source: Sun Yat-sen University
• Contact: Yingfeng Zheng, M.D. Ph.D.
• Phone: +8613922286455
• Email: zhyfeng[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• 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	Zhognshan Ophthalmic Center (Zhujiang New Town Branch), Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
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