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NCT Number: NCT06652594

"Eye" Education for Parents and Myopia 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.

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Key information

Age range

5 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beijing Tongren Hospital, Beijing

Beijing, Beijing Municipality, 100730, China

Location contact

Shi-Ming Li, MD, PHD

CONTACT

[email protected]

+86-010-58269920

Shi-Ming Li, MD, PHD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children aged 5-17;
  • 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;
  • Best corrected visual acuity of either eye were all ≥ 1.0;
  • The range of myopia in either eye was -15 D ≤ SE ≤ +2.0 D;
  • Astigmatism of either eye less than -5.0 D;
  • Anisometropia ≤ -1.5 D;
  • There was no active ocular inflammatory diseases; no obvious corneal cloud or macula, anormal corneal topography, and no tendency of keratoconus.
  • Intraocular pressure of either eye is of 10 to 21 mmHg;
  • On the basis of full understanding, children and their guardians sign the informed consent;

Exclusion criteria

  • Amblyopia: best corrected visual acuity (BCVA) of either eye less than 1.0 for children over 6 years old;
  • Active ocular inflammatory diseases, such as uveitis and other inflammatory diseases;
  • Secondary myopia, genetic disease or connective tissue- related myopia;
  • Moderate or severe ptosis;
  • Congenital cataract, glaucoma;
  • Other fundus diseases other than myopic related fundus lesions;
  • Intraocular or refractive surgery history;
  • 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.

Treatment and study plan

Eye Education Intervention

Behavioral

Doctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.

Control

Behavioral

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

Primary outcomes

  1. Axial Length

    Time frame: 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.

  2. Cycloplegic Refraction

    Time frame: Baseline, 1 month, 3 months, 6 months.

    Cycloplegic refractive errors were measured with an autorefractor.

Secondary outcomes

  1. Visual acuity

    Time frame: 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.

  2. Anxiety Disorder Screening 7-item Scale

    Time frame: Baseline, 6 month

    Assessing changes in parents' anxiety before and after the intervention.

  3. Strengths and Difficulties Questionnaire

    Time frame: Baseline, 6 month.

    Assessing changes in parent-child relationships before and after the intervention.

Other outcomes

  1. Fundus Image

    Time frame: Baseline, 1 month, 3 months, 6 months.

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Shi-Ming Li, MD, PHD

CONTACT

[email protected]

+86-010-58269920

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Oct 22, 2024
Registry last updated
Oct 22, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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