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

NCT ID: NCT04284111

Last Updated: 2020-02-28

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

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-26

Study Completion Date

2021-08-31

Brief Summary

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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

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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.

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 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.

Orthokeratology lenses

Intervention Type DEVICE

Orthokeratology lenses

Interventions

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Orthokeratology lenses

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

Sponsors

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Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Xialin Liu, M.D. Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Zhongshan Ophthalmic Center, Sun Yat-sen University

Locations

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Hefei Bright Eye Hospital

Hefei, Anhui, China

Site Status RECRUITING

Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University

Guangzhou, Guangdong, China

Site Status RECRUITING

Wuhan Bright Eye hospital

Wuhan, Hubei, China

Site Status RECRUITING

Nanchang Bright Eye Hospital

Nanchang, Jiangxi, China

Site Status RECRUITING

Jinan Bright Eye Hospital

Jinan, Shandong, China

Site Status RECRUITING

Shanghai Bright Eye Hospital

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Chengdu Bright Eye Hospital

Chengdu, Sichuan, China

Site Status RECRUITING

Kunming Bright Eye hospital

Kunming, Yunnan, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xialin Liu, M.D. Ph.D.

Role: CONTACT

Phone: +8613719109851

Email: [email protected]

Facility Contacts

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Lijuan Wang, M.D

Role: primary

Xialin Liu, MD.

Role: primary

Shan Lin, M.D

Role: primary

Yue Yan, M.D

Role: primary

Ping Wang, M.D

Role: primary

Yan Yan, M.D

Role: primary

Min Cui, M.D

Role: primary

Xianghua Yuan, M.D

Role: primary

References

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Wang D, Ding X, Liu B, Zhang J, He M. Longitudinal changes of axial length and height are associated and concomitant in children. Invest Ophthalmol Vis Sci. 2011 Oct 10;52(11):7949-53. doi: 10.1167/iovs.11-7684.

Reference Type BACKGROUND
PMID: 21896861 (View on PubMed)

Other Identifiers

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2020KYPJ019

Identifier Type: -

Identifier Source: org_study_id