Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children

The study used children aged 6-18 as subjects to evaluate the efficacy and safety of naked eye 3D vision training for the prevention and control of myopia in adolescents. A total of 250 subjects were recruited from Zhongshan Ophthalmology Center of Sun Yat-sen University, Shenzhen People's Hospital and Foshan Women's and Children's Hospital, with 1:1 as intervention group and control group. The study assumes that daily naked eye 3D vision training can effectively control the speed of axial elongation and the progression of myopia. The main indicators were the use of optical biometrics to detect the subjects' initial axial length and the axial length after 1 month, 3 months and 6 months of intervention. Secondary indicators were refraction, uncorrected visual acuity, best corrected visual acuity, choroidal thickness, and binocular vision.

Study Overview

• Status: Not yet recruiting
• Conditions: Axial Elongation; Adolescents and Children; Naked Eye 3D Vision Training; Visual Function
• Intervention / Treatment: Behavioral: Naked eye 3D vision training

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age 6~18 years old (including 6 years old and 18 years old), gender is not limited;
2. Written informed consent signed by the child and legal guardian has been obtained;
3. Patients who have visited the research center in the past month, diagnosed as myopia according to the "Guidelines for the Prevention and Treatment of Myopia" issued by the General Office of the National Health Commission (Guoweiban Medical Letter [2018] No. 393), and the spherical equivalent power is -0.75 to -6.00 Diopter (D) (including -0.75 and -6.00 D);
4. Astigmatism≤4.00 D, anisometropia≤4.00 D;
5. Monocular international standard logarithmic visual acuity after spectacle correction ≥20/25;
6. The subject's guardian can understand the purpose of this study, and the subject can cooperate with the treatment and related eye examinations.

Exclusion Criteria:

1. Any eye of the subject suffers from overt strabismus, or any other pathological changes in the eyeball or acute inflammatory disease of the eye;
2. Subjects who may suffer from eye diseases that affect vision or refractive errors (such as cataract and other lens damage diseases, glaucoma, macular degeneration, keratopathy, uveitis, retinal detachment, severe vitreous opacity, etc.);
3. Systemic diseases: those with a history of immune system diseases, central nervous system diseases, Down syndrome, asthma, severe heart and lung function, severe liver and kidney dysfunction;
4. Binocular hyperopia cannot be corrected to logarithmic visual acuity of 20/25;
5. The subject has or is undergoing myopia control treatment within the past 1 month, such as atropine eye drops, orthokeratology lenses, progressive lenses, bifocal lenses, etc.;
6. Photophobia or unable to open eyes normally due to keratitis, trichiasis, trauma, etc. in any eye of the subjects;
7. Subjects participated in other clinical studies 4 weeks before enrollment;
8. For safety reasons or the interests of patients, the investigator believes that patients should not participate in other situations in this study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: control group
Experimental: intervention group	Behavioral: Naked eye 3D vision training; 20 minutes of naked eye 3D vision training every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of axial length	mm	baseline, 1st months, 3rd months, 6th months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the change of vision	Diopter	baseline, 1st months, 3rd months, 6th months
the change of choroidal thickness	mm	baseline, 1st months, 3rd months, 6th months
the change of adjustment range	Diopter	baseline, 1st months, 3rd months, 6th months
the change of adjust sensitivity	cycle per minute	baseline, 1st months, 3rd months, 6th months

Collaborators and Investigators

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2022
• Primary Completion (Anticipated): October 1, 2022
• Study Completion (Anticipated): October 1, 2022

Study Registration Dates

• First Submitted: July 11, 2022
• First Submitted That Met QC Criteria: July 18, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 18, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia
• Other Study ID Numbers: 2021KYPJ193

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No