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

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04284111
• Collaborator: (none)
• Enrollment: 1,000
• Locations: 8
• Anticipated Duration (Months): 17.1
• Patients Per Site: 125
• Patients Per Site Per Month: 7.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Myopia	Device: Orthokeratology lenses

Detailed 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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 1000 participants
• Observational Model: Case-Only
• Time Perspective: Prospective
• Official Title: A Prospective, Multi-center Study of the Effect of Orthokeratology on Myopia Progression in Chinese Children
• Actual Study Start Date: Feb 26, 2020
• Anticipated Primary Completion Date: Mar 1, 2021
• Anticipated Study Completion Date: Aug 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
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.	Device: Orthokeratology lenses; Orthokeratology lenses

Outcome Measures

Primary Outcome Measures

1. AUROC of the prediction algorithm for identifying fast progressing myopes [1 year]

   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.

Secondary Outcome Measures

1. Sensitivity and specificity of the prediction algorithm for identifying fast progressing myopes [1 year]

   The investigators will estimate sensitivity and specificity of the predictive algorithm for identifying fast progressing myopes.

2. Performance of an algorithm for predicting AL [1 year]

   The investigators will use mean absolute error (MAE), R square to evaluate the performance.

3. Performance of an algorithm for predicting spherical equivalent refractive error [1 year]

   The investigators will use mean absolute error (MAE), R square to evaluate the performance.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 8 Years to 15 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hefei Bright Eye Hospital	Hefei	Anhui	China
2	Zhongshan Ophthalmic Center (Haizhu Branch), Sun Yat-sen University	Guangzhou	Guangdong	China
3	Wuhan Bright Eye hospital	Wuhan	Hubei	China
4	Nanchang Bright Eye Hospital	Nanchang	Jiangxi	China
5	Jinan Bright Eye Hospital	Jinan	Shandong	China
6	Shanghai Bright Eye Hospital	Shanghai	Shanghai Province	China
7	Chengdu Bright Eye Hospital	Chengdu	Sichuan	China
8	Kunming Bright Eye hospital	Kunming	Yunnan	China

Sponsors and Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

• Principal Investigator: Xialin Liu, M.D. Ph.D., Zhongshan Ophthalmic Center, Sun Yat-sen University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.

• Responsible Party: Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT04284111
• Other Study ID Numbers: 2020KYPJ019
• First Posted: Feb 25, 2020
• Last Update Posted: Feb 28, 2020
• Last Verified: Feb 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Feb 28, 2020