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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04275635
Enrollment
3000
Registered
2020-02-19
Start date
2020-02-25
Completion date
2021-08-31
Last updated
2020-03-16

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 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.

Interventions

Orthokeratology lenses

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

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

MeasureTime frameDescription
AUROC of the prediction algorithm for identifying fast progressing myopes1 yearAge-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

MeasureTime frameDescription
Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes1 yearThe investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.
Performance of an algorithm for predicting AL1 yearThe investigators will use mean absolute error (MAE), R square to evaluate the performance.
Performance of an algorithm for predicting spherical equivalent refractive error1 yearThe investigators will use mean absolute error (MAE), R square to evaluate the performance.

Countries

China

Contacts

Primary ContactYingfeng Zheng, M.D. Ph.D.
zhyfeng@mail.sysu.edu.cn+8613922286455

Outcome results

None listed

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