"Eye" Education for Parents and Myopia Control in Children
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-17
SponsorBeijing Tongren Hospital
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Eye Education Intervention
BehavioralDoctors and nurses will educate parents about eye health in response to theirchild's myopia progression at baseline, 1 month, 3 months, 6 months.
Control
BehavioralParents in the control group will not receive eye health education informationfrom doctors and nurses.
Treatment groups
498 Participants
are divided into 2 treatment groupsGroup A: Eye Education InterventionExperimental treatment 1 intervention
Group B: ControlExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 1 month, 3 months, 6 months.2
Cycloplegic Refraction
Cycloplegic refractive errors were measured with an autorefractor.
Time frame
Baseline, 1 month, 3 months, 6 months.Secondary outcomes
1
Visual acuity
The visual acuity of the children is assessed through a self-administered vision test conducted by their guardians via WeChat mini program.
Time frame
Baseline, 1 month, 3 months, 6 months.2
Anxiety Disorder Screening 7-item Scale
Assessing changes in parents' anxiety before and after the intervention.
Time frame
Baseline, 6 month3
Strengths and Difficulties Questionnaire
Assessing changes in parent-child relationships before and after the intervention.
Time frame
Baseline, 6 month.Other outcomes
1
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.
Time frame
Baseline, 1 month, 3 months, 6 months.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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