"Eye" Education for Parents and Myopia Control in Children

Not Applicable

Not yet recruiting

• Conditions: Anxiety; Children; Health Education

• Registration Number: NCT06652594
• Lead Sponsor: Beijing Tongren Hospital

Brief Summary

This is a randomized controlled trial aimed to explore the effect of behavioral interventions based on doctors' and nurses' health education on the onset and development of myopia in children's. Participants were randomly assigned to one of two groups: eye health intervention, or the control group. Intervention group's parents would reveive eye health education in response to their children's myopia progression at baseline, 1 month, 3 months, and 6 months, while the control group did not receive any. Visual acuity, cycloplegic refraction, axial length, Strengths and Difficulties Questionnaire, and Generalized Anxiety Disorder 7-item Scale were the main outcomes and measures.

Detailed Description

After doctors' and nurses' education, parents would keep a diary to regulate the children's "Sedentary", "Sunshine", "Sleep", "Screen", and "Stress" that is, the "5S" eye education. To urging parents pay attention to the children's eye behavior every day, and targeted to children "eye" education to delay the occurrence and development of myopia and reduce the incidence of high myopia.

Study Timeline

• Status Verified: 2024-10
• Study Start: 2024-10-19
• Study First Submitted: 2024-10-21
• Study First Submitted QC: 2024-10-21
• Last Update Submitted: 2024-10-21
• Study First Posted: 2024-10-22
• Last Update Posted: 2024-10-22
• Primary Completion: 2025-04-19
• Study Completion: 2025-04-19

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 498

Inclusion Criteria

Not provided

Exclusion Criteria

1. Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
2. Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
3. Secondary myopia, genetic disease or connective tissue- related myopia;
4. Moderate or severe ptosis;
5. Congenital cataract, glaucoma;
6. Other fundus diseases other than myopic related fundus lesions;
7. Intraocular or refractive surgery history;
8. The refractive medium is turbid, and it is impossible to take a clear fundus image; (9)Unable to cooperate with fundus image shooting and other examination;

(10)Do not receive cycloplegia or have contraindications; (11)Poor overall condition, unable to follow up for a long time; (12)The subject refuses to participate in the research; (13)Other cases in which the researcher judges that it is not suitable for participation in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Axial Length	Baseline, 1 month, 3 months, 6 months.	Ocular biometry was used for measuring the axial length, which is the physical distance between the anterior corneal pole and the retinal structure at the posterior pole.
Cycloplegic Refraction	Baseline, 1 month, 3 months, 6 months.	Cycloplegic refractive errors were measured with an autorefractor.

Secondary Outcome Measures

Name	Time	Method
Visual acuity	Baseline, 1 month, 3 months, 6 months.	The visual acuity of the children is assessed through a self-administered vision test conducted by their guardians via WeChat mini program.
Anxiety Disorder Screening 7-item Scale	Baseline, 6 month	Assessing changes in parents' anxiety before and after the intervention.
Strengths and Difficulties Questionnaire	Baseline, 6 month.	Assessing changes in parent-child relationships before and after the intervention.

Trial Locations

Locations (1)

Beijing Tongren Hospital, Beijing; 🇨🇳 Beijing, Beijing, China