The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin
1 other identifier
interventional
4,000
1 country
1
Brief Summary
The study aimed to collect multi-factor information on school-age children with pre-clinical myopia, and to identify the initial factors and warning signs of myopia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2020
CompletedFirst Submitted
Initial submission to the registry
December 25, 2022
CompletedFirst Posted
Study publicly available on registry
January 20, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedMay 7, 2024
May 1, 2024
4.7 years
December 25, 2022
May 5, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
The rate of new-onset myopia
The number of new children with myopia was counted
Through study completion, an average of 1 year
The changes of refractive error
The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
Every 6 months, up to 3 years
The changes of axial length
The axial length was measured by a biological measuring instrument.
Every 6 months, up to 3 years
Study Arms (3)
Home-school training group
EXPERIMENTALThere was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.
School training group
EXPERIMENTALThere was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.
No training group
NO INTERVENTIONThere was no such treatment for students.
Interventions
Letter Chart Accomodative Rock Training for 2 minutes each time
Letter Chart Accomodative Rock Training for 2 minutes each time
Eligibility Criteria
You may qualify if:
- All students in grades 1 to 4
- Can cooperate with the examination of students
You may not qualify if:
- Obvious strabismus and amblyopia
- Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
- History of ocular surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tiajin Eye Hospital
Tianjin, Tianjin Municipality, 300020, China
Related Publications (1)
Jonas JB, Ang M, Cho P, Guggenheim JA, He MG, Jong M, Logan NS, Liu M, Morgan I, Ohno-Matsui K, Parssinen O, Resnikoff S, Sankaridurg P, Saw SM, Smith EL 3rd, Tan DTH, Walline JJ, Wildsoet CF, Wu PC, Zhu X, Wolffsohn JS. IMI Prevention of Myopia and Its Progression. Invest Ophthalmol Vis Sci. 2021 Apr 28;62(5):6. doi: 10.1167/iovs.62.5.6.
PMID: 33909032BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 25, 2022
First Posted
January 20, 2023
Study Start
May 1, 2020
Primary Completion
December 31, 2024
Study Completion
December 31, 2024
Last Updated
May 7, 2024
Record last verified: 2024-05