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

NCT05468775 | Unknown

• 1 other identifier: 2021KYPJ193
• Study Type: interventional
• Target: 250
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Adolescents and Children; Axial Elongation; Naked Eye 3D Vision Training; Visual Function

Outcome Measures

Primary Outcomes (1)

• the change of axial length

  mm

  baseline, 1st months, 3rd months, 6th months

Secondary Outcomes (4)

• the change of vision

  baseline, 1st months, 3rd months, 6th months

• the change of choroidal thickness

  baseline, 1st months, 3rd months, 6th months

• the change of adjustment range

  baseline, 1st months, 3rd months, 6th months

• the change of adjust sensitivity

  baseline, 1st months, 3rd months, 6th months

Study Arms (2)

intervention group

EXPERIMENTAL

Behavioral: Naked eye 3D vision training

control group

NO INTERVENTION

Interventions

Naked eye 3D vision training BEHAVIORAL

20 minutes of naked eye 3D vision training every day

intervention group

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 6\~18 years old (including 6 years old and 18 years old), gender is not limited;
• Written informed consent signed by the child and legal guardian has been obtained;
• 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);
• Astigmatism≤4.00 D, anisometropia≤4.00 D;
• Monocular international standard logarithmic visual acuity after spectacle correction ≥20/25;
• The subject's guardian can understand the purpose of this study, and the subject can cooperate with the treatment and related eye examinations.

You may not qualify if:

• Any eye of the subject suffers from overt strabismus, or any other pathological changes in the eyeball or acute inflammatory disease of the eye;
• 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.);
• 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;
• Binocular hyperopia cannot be corrected to logarithmic visual acuity of 20/25;
• 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.;
• Photophobia or unable to open eyes normally due to keratitis, trichiasis, trauma, etc. in any eye of the subjects;
• Subjects participated in other clinical studies 4 weeks before enrollment;
• For safety reasons or the interests of patients, the investigator believes that patients should not participate in other situations in this study.

Sponsors & Collaborators

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

Related Publications (1)

• Xie R, Zhao F, Yu J, Luo B, Jiang Z, Qiu X, Cao Y, Yang Y, Chen K, Zhang Y, Luo X, Wang Z, Zhu Y, Zhuo Y. Naked-Eye 3-Dimensional Vision Training for Myopia Control: A Randomized Clinical Trial. JAMA Pediatr. 2024 Jun 1;178(6):533-539. doi: 10.1001/jamapediatrics.2024.0578.

  PMID: 38587852 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 21, 2022
• Study Start: August 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07