Community Intervention and Demonstration Area Construction

Myopia Clinical Trial

Official title:

Research on Precise Myopia Prevention and Control Technology and Demonstration Application for Children and Adolescent

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05715424
• Other study ID #: 20210735
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: April 2024
• Source: Anhui Medical University
• Contact: FangBiao Tao, Professor
• Phone: +86 19966513010
• Email: vipur8[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The objective of this intervention study was to understand the visual health status of nearly one million children and adolescents in ten provinces in China, and then to conduct intervention and evaluate the effect of intervention measures with the development of myopia as the outcome indicator. The study will be conducted in the form of a stepped intervention and will answer the following questions.

Current China children and adolescent's vision health, including the different degrees of myopia prevalence, and farsightedness reserve status. To evaluate the implementation and effect of eight appropriate technologies and six interventions developed in this study, to reduce the incidence of myopia among children and adolescents in China, to achieve the purpose of nationwide application.

In the early stage of this study, a baseline survey will be conducted on participants. In the middle stage, participants will be required to adjust the seat height regularly and increase the time for outdoor activities, etc. In the later stage, intervention measures will be evaluated based on the overall research situation to consider national promotion.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000000
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• ? Kindergarten kids.

• Grade of 1 to 6 in elementary schools.

• Grade of 1 to 3 in middle schools.

• Grade of 1 to 3 in high schools.

• Sign the informed consent.

Exclusion Criteria:

• ?Visual defect or other eye diseases.

• wearing orthokeratology; refractive surgery history.

• Not considered suitable for inclusion in the study by the investigator.

Related Conditions & MeSH terms

• Myopia
• Refractive Errors

Intervention

Other:
• Six interventions for children and adolescents
Vision Health Record Establishment and Myopia Risk Assessment. Evaluation of vision care behavior and development of reasonable eye use behavior. Health education for teachers and parents. Action to improve the reading and writing environment at home and school. One hour of outdoor activities in and out of school during the day. Myopia grading management and medical correction action.

Locations

Country	Name	City	State
China	Anqing myopia scene	Anqing	Anhui

Sponsors (3)

Lead Sponsor	Collaborator
Anhui Medical University	Beijing Center for Disease Control and Prevention, Shanghai Eye Disease Prevention and Treatment Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in questionnaire survey	Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.	Baseline, 6 months, 1 year, 1.5 years, 2 years
Primary	Changes in uncorrected vision within two years	Uncorrected visual acuity (UCVA) was measured for the right eye, then the left eye, with a E Standard Logarithm Vision Acuity Chart (GB11533-2011) in 5-grade notation (5- LogMAR), with illumination of the chart around 500lx. If one of the eyes UCVA was less than 5.0, then tests with combined lenses were conducted among the poor eye-sighted for confirming the types of ametropia (normal, myopia, hyperopia or other eye diseases).All the measurements were recorded.	Baseline, 6 months, 1 year, 1.5 years, 2 years
Primary	Changes in visual acuity in computer optometry	Optometry Automated computerized optometry is performed by an optometrist. Automatic optometry instrument using desktop computer automatic optometry, equipment requirements should conform to the "ISO10342-2010 Ophthalmic instruments: Optometry" provisions.	Baseline, 6 months, 1 year, 1.5 years, 2 years
Primary	Changes in visual acuity during dilated pupil optometry	Between 5% and 10% of the participants were selected for Dilated pupil optometry.	Baseline, 6 months, 1 year, 1.5 years, 2 years
Secondary	Eye protection diary	Daily questionnaire based on the development of myopia prevention and control in children and adolescents.	Three months.
Secondary	Qualitative interview	Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.	Baseline, 1 year, 2 years