The Monitoring and Intervention of Refractive Changes in Children and Teenagers in Tianjin

Not Applicable

Active, not recruiting

• Conditions: Myopia; High Myopia
• Interventions: Behavioral: Home training; Behavioral: School training

• Registration Number: NCT05691296
• Lead Sponsor: Tianjin Eye Hospital

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.

Detailed Description

The incidence of myopia is high in China. At present, the mechanism of myopia is unclear, and the main theories are genetic and environmental aspects. Many factors may affect the occurrence and development of myopia in students, such as ocular biological parameters, peripheral refractive state, differences in binocular vision function, eye habits, and outdoor time. In this study, the multi-factor information on pre-clinical myopia in school-age children was collected to find out the initial factors and warning signals of myopia.

Study Timeline

• Study Start: 2020-05-01
• Study First Submitted: 2022-12-25
• Study First Submitted QC: 2023-01-11
• Study First Posted: 2023-01-20
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-05
• Last Update Posted: 2024-05-07
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• All students in grades 1 to 4
• Can cooperate with the examination of students

Exclusion Criteria

• Obvious strabismus and amblyopia
• Eye diseases that affect vision, such as congenital cataracts, glaucoma, and retinal diseases
• History of ocular surgery

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Home-school training group	School training	There was a Letter Chart Accomodative Rock Training for accommodation facility at home and school everyday. This training usually lasted 2 minutes each time.
Home-school training group	Home training	There 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	School training	There was a Letter Chart Accomodative Rock Training for accommodation facility only at school everyday. This training usually lasted 2 minutes each time.

Primary Outcome Measures

Name	Time	Method
The rate of new-onset myopia	Through study completion, an average of 1 year	The number of new children with myopia was counted
The changes of refractive error	Every 6 months, up to 3 years	The changes of refractive error between visit time and baseline which was obtained with a computer refractometer.
The changes of axial length	Every 6 months, up to 3 years	The axial length was measured by a biological measuring instrument.

Trial Locations

Locations (1)

Tiajin Eye Hospital; 🇨🇳 Tianjin, Tianjin, China