A Multi-center Study of the Effect of Orthokeratology on Myopia Progression
A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children
1 other identifier
observational
1,000
1 country
8
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2020
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2020
CompletedFirst Posted
Study publicly available on registry
February 25, 2020
CompletedStudy Start
First participant enrolled
February 26, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2021
CompletedFebruary 28, 2020
February 1, 2020
1 year
February 21, 2020
February 26, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
AUROC of the prediction algorithm for identifying fast progressing myopes
Age-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.
1 year
Secondary Outcomes (3)
Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes
1 year
Performance of an algorithm for predicting AL
1 year
Performance of an algorithm for predicting spherical equivalent refractive error
1 year
Study Arms (1)
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.
Interventions
Eligibility Criteria
1,000 children from 8 hospitals in China plan to wear orthokeratology lenses for myopia control.
You may qualify if:
- D≤SER≤-0.5D
- Astigmatism≤2.0D
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hefei Bright Eye Hospital
Hefei, Anhui, China
Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University
Guangzhou, Guangdong, China
Wuhan Bright Eye hospital
Wuhan, Hubei, China
Nanchang Bright Eye Hospital
Nanchang, Jiangxi, China
Jinan Bright Eye Hospital
Jinan, Shandong, China
Shanghai Bright Eye Hospital
Shanghai, Shanghai Municipality, China
Chengdu Bright Eye Hospital
Chengdu, Sichuan, China
Kunming Bright Eye hospital
Kunming, Yunnan, China
Related Publications (1)
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.
PMID: 21896861BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xialin Liu, M.D. Ph.D.
Zhongshan Ophthalmic Center, Sun Yat-sen University
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2020
First Posted
February 25, 2020
Study Start
February 26, 2020
Primary Completion
March 1, 2021
Study Completion
August 1, 2021
Last Updated
February 28, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share