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

NCT ID: NCT05468775

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-01
• Study Completion Date: 2022-10-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

intervention group

Group Type: EXPERIMENTAL

Naked eye 3D vision training

Intervention Type: BEHAVIORAL

20 minutes of naked eye 3D vision training every day

control group

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Naked eye 3D vision training

20 minutes of naked eye 3D vision training every day

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zhongshan Ophthalmic Center, Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Yehong Zhuo

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: DERIVED

PMID: 38587852 (View on PubMed)

Other Identifiers

2021KYPJ193

Identifier Type: -

Identifier Source: org_study_id