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

• Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05468775
• Collaborator: (none)
• Enrollment: 250
• Arms: 2
• Anticipated Duration (Months): 2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adolescents and Children; Axial Elongation; Naked Eye 3D Vision Training; Visual Function	Behavioral: Naked eye 3D vision training	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 250 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. the change of axial length [baseline, 1st months, 3rd months, 6th months]

   mm

Secondary Outcome Measures

1. the change of vision [baseline, 1st months, 3rd months, 6th months]

   Diopter

2. the change of choroidal thickness [baseline, 1st months, 3rd months, 6th months]

   mm

3. the change of adjustment range [baseline, 1st months, 3rd months, 6th months]

   Diopter

4. the change of adjust sensitivity [baseline, 1st months, 3rd months, 6th months]

   cycle per minute

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Yehong Zhuo, Clinical Professor, Zhongshan Ophthalmic Center, Sun Yat-sen University
• ClinicalTrials.gov Identifier: NCT05468775
• Other Study ID Numbers: 2021KYPJ193
• First Posted: Jul 21, 2022
• Last Update Posted: Jul 21, 2022
• Last Verified: Jul 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Myopia

Study Results

No Results Posted as of Jul 21, 2022