"Eye" Education for Parents and Myopia Control in Children

Capital Medical University

Status: Not yet enrolling

Conditions: Children; Anxiety; Health Education

Treatments: Behavioral: Eye Education Intervention; Behavioral: Control

Study type: Interventional

Funder types: Other

Identifiers

NCT06652594

2024-2G-1081

Details and patient eligibility

About

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.

Full 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.

Enrollment: 498 estimated patients

Sex: All

Ages: 5 to 17 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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498 participants in 2 patient groups

Eye Education Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Eye Education Intervention

Control

Experimental group

Description:

Parents in the control group will not receive eye health education information from doctors and nurses.

Treatment:

Behavioral: Control