"Eye" Education for Parents and Myopia Control in Children

Effect of "eye" Education for Parents on Myopia Prevention and Control in Children

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Anxiety; Children; Health Education
• Intervention / Treatment: Behavioral: Eye Education Intervention; Behavioral: Control

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 Type: Interventional
• Enrollment (Estimated): 498
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Shi-Ming Li, MD, PHD; Phone Number: +86-010-58269920; Email: lishiming81@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Beijing Tongren Hospital, Beijing
      • Contact: Shi-Ming Li, MD, PHD; Phone Number: +86-010-58269920; Email: lishiming81@163.com
      • Contact: Shi-Ming Li, MD, PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria

1. Children aged 5-17;
2. Removing flexible lenses for at least 1 week, flexible astigmatism and hard lenses for at least 3 weeks, orthokeratology lenses for at least 3 months;
3. Best corrected visual acuity of either eye were all ≥ 1.0;
4. The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
5. Astigmatism of either eye less than -5.0 D;
6. Anisometropia ≤ -1.5 D;
7. There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
8. Intraocular pressure of either eye is of 10 to 21 mmHg;
9. On the basis of full understanding, children and their guardians sign the informed consent;

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eye Education Intervention; Doctors and nurses will educate parents about eye health in response to their child's myopia progression at baseline, 1 month, 3 months, 6 months.	Behavioral: Eye Education Intervention; Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.
Experimental: Control; Parents in the control group will not receive eye health education information from doctors and nurses.	Behavioral: Control; Parents in the control group will not receive eye health education informationfrom doctors and nurses.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Axial Length	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.	Baseline, 1 month, 3 months, 6 months.
Cycloplegic Refraction	Cycloplegic refractive errors were measured with an autorefractor.	Baseline, 1 month, 3 months, 6 months.

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fundus Image	Two fundus photographs were taken for each subject, centered on the optic disc and macula with a 45° field of view. If the quality of the photographs was low, they were retaken.	Baseline, 1 month, 3 months, 6 months.

Collaborators and Investigators

• Sponsor: Beijing Tongren Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): October 19, 2024
• Primary Completion (Estimated): April 19, 2025
• Study Completion (Estimated): April 19, 2025

Study Registration Dates

• First Submitted: October 21, 2024
• First Submitted That Met QC Criteria: October 21, 2024
• First Posted (Actual): October 22, 2024

Study Record Updates

• Last Update Posted (Actual): October 22, 2024
• Last Update Submitted That Met QC Criteria: October 21, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2024-2G-1081

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No