- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04005014
Effect of Using Myopia Prediction Algorithm
July 1, 2019 updated by: Haotian Lin, Sun Yat-sen University
Effect of Using Myopia Prediction Algorithm on Children's Eye Refraction in China: a Multi-center Randomized Control Trial
In this study, the investigators aim to perform a prospective, randomized controlled study to compare the myopia development between children using myopia prediction algorithm and children without using myopia prediction algorithm.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
We propose to enroll Grade 3 children from primary schools in China.
Children will be given examinations of visual acuity, eye refraction and biometrics, and be assigned to two groups: participants in group A use myopia prediction algorithm to predict myopia development, while in Group B, the participants do not use myopia prediction algorithm to predict myopia development.
The visual acuity, eye refraction and biometrics will be investigated over the one-year follow-up period, aiming at comparison of actual myopia development between the two groups.
Study Type
Interventional
Enrollment (Anticipated)
1680
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yahan Yang
- Phone Number: +8615521013933
- Email: yah.yang39@hotmail.com
Study Contact Backup
- Name: Haotian Lin
- Phone Number: +8613802793086
- Email: haot.lin@hotmail.com
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
8 years to 9 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children at Grade 3 (aged 8-9)
- Has the record of eye refraction examined in the past year
- Written informed consents provided
Exclusion Criteria:
- Definitive diagnosis of other ocular abnormalities except for refractive error
- Previous eye surgery
- Unwilling to participate in this trial
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Using myopia prediction algorithm
After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
Meanwhile, myopia prediction algorithm will be used to predict SE and presence of high myopia in the subsequent 10 years.
|
Candidate predictors included age at examination, SE, and annual progression rate.
Using these predictors, the algorithm will be used to predict SE and whether patients will progress to high myopia in the subsequent 10 years.
|
No Intervention: Not using myopia prediction algorithm
After examination of visual acuity, eye refraction and biometrics, the examination results are shown to the children.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of SER development of at least -0.5 dioptres (D)
Time Frame: Up to 1 year
|
SER: sphere + ½ 360 cylinder; SER development of at least -0.5 dioptres: SER2 - SER1≤-0.5D; SER1: SER at baseline; SER2: SER up to 1 year
|
Up to 1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in SER \and AL
Time Frame: Up to 1 year
|
Changes in SER \and AL will be calculated; AL: axial length
|
Up to 1 year
|
Changes in proportion of children using atropine
Time Frame: Up to 1 year
|
Changes in proportion of children using atropine will be calculated
|
Up to 1 year
|
Changes in proportion of children using orthokeratology lenses
Time Frame: Up to 1 year
|
Changes in proportion of children using orthokeratology lenses will be calculated
|
Up to 1 year
|
Changes in proportion of children using spectacles
Time Frame: Up to 1 year
|
Changes in proportion of children using spectacles will be calculated
|
Up to 1 year
|
Changes in child's average outdoor activity time per day
Time Frame: Up to 1 year
|
Changes in child's average outdoor activity time per day will be calculated
|
Up to 1 year
|
Changes in child's average screen time per day
Time Frame: Up to 1 year
|
Changes in child's average screen time per day will be calculated
|
Up to 1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
July 8, 2019
Primary Completion (Anticipated)
January 31, 2021
Study Completion (Anticipated)
January 31, 2021
Study Registration Dates
First Submitted
July 1, 2019
First Submitted That Met QC Criteria
July 1, 2019
First Posted (Actual)
July 2, 2019
Study Record Updates
Last Update Posted (Actual)
July 2, 2019
Last Update Submitted That Met QC Criteria
July 1, 2019
Last Verified
July 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCPMOH2019-China-1
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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