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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

3000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-25

Study Completion Date

2021-08-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Myopia

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Children with myopia

A total of 3,000 children from Zhongshan Ophthalmic Center is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing Ortho-K.

Orthokeratology lenses

Intervention Type DEVICE

Orthokeratology lenses

Interventions

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Orthokeratology lenses

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

8 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No