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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04284111

Enrollment

1000

Registered

2020-02-25

Start date

2020-02-26

Completion date

2021-08-31

Last updated

2020-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

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.

Interventions

DEVICEOrthokeratology lenses

Orthokeratology lenses

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

8 Years to 15 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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 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.

Countries

China

Contacts

Primary ContactXialin Liu, M.D. Ph.D.

liuxialin@gzzoc.com+8613719109851

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026