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

Sun Yat-sen University

Status: Unknown

Conditions: Myopia

Treatments: Device: Orthokeratology lenses

Study type: Observational

Funder types: Other

Identifiers

NCT04284111

2020KYPJ019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,000 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

1,000 participants in 1 patient group

Children with myopia

Description:

A total of 1,000 children from 8 hospitals in China is required to undergo ophthalmic examinations and complete questionnaires at baseline and 1yr after wearing ortho-k lenses.

Treatment:

Device: Orthokeratology lenses