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

Sun Yat-sen University

Status: Unknown

Conditions: Myopia

Treatments: Device: Orthokeratology lenses

Study type: Observational

Funder types: Other

Identifiers

NCT04275635

2020KYPJ018

Details and patient eligibility

About

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

Full 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.

Enrollment: 3,000 estimated patients

Sex: All

Ages: 8 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

3,000 participants in 1 patient group

Children with myopia

Description:

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.

Treatment:

Device: Orthokeratology lenses