An interventional study of Six interventions for children and adolescents in Myopia and Refractive Errors, sponsored by Anhui Medical University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-04-09.
Sponsored by Anhui Medical University · Not applicable, Interventional, and Prevention
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.
1,159 studies on the registry are indexed under Myopia; 225 are open to participants now.
This study's planned enrollment of 1,000,000 is above the median of 78 across 923 interventional studies indexed under Myopia.
Browse Myopia studies →Anhui Medical University is the lead sponsor of 104 studies on the registry; 50 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
● Kindergarten kids.
Exclusion Criteria:
●Visual defect or other eye diseases.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster A. The intervention was administered at month 6 and monitored for two years.
Other: Six interventions for children and adolescents
The study population (school-based) was divided into four clusters. Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster B. The intervention was administered at month 12 and monitored for one and a half years.
Other: Six interventions for children and adolescents
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention. and one cluster was randomly selected as Cluster C. The intervention was administered at month 18 and monitored for a continuous period of one year.
Other: Six interventions for children and adolescents
The study population (school-based) was divided into four clusters.Each cluster will receive the same intervention.and one cluster was randomly selected as Cluster D. The intervention was implemented at month 18 and an evaluation of the effect of the intervention was performed.
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.
Changes in questionnaire survey
Questionnaires based on myopia prevention and control for children and adolescents, including a questionnaire on myopia in children and adolescents.
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
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.
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
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.
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Changes in visual acuity during dilated pupil optometry
Between 5% and 10% of the participants were selected for Dilated pupil optometry.
Time frame: Baseline, 6 months, 1 year, 1.5 years, 2 years
Eye protection diary
Daily questionnaire based on the development of myopia prevention and control in children and adolescents.
Time frame: Three months.
Qualitative interview
Based on the interview outline on myopia prevention and control, some randomly selected students, parents, teachers and related departments were investigated.
Time frame: Baseline, 1 year, 2 years
Plan to share: No
No publications or documents are linked to this record.
Started Dec 2022 (actual). Primary completion is estimated for Dec 2024, 24 months after the start.
Of 200 non-industry interventional studies with no phase under Myopia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 44. This study's planned 24 months is close to that.
Counting every sponsor, half of 434 studies reached it within 14 months; a quarter within 3 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
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