Clinical trial NCT05468775: Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
Official title: Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adolescents and Children
Axial Elongation
Naked Eye 3D Vision Training
Visual Function
Lead sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 250
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: the change of axial length
timeFrame: baseline, 1st months, 3rd months, 6th months
Secondary outcomes:
measure: the change of vision
timeFrame: baseline, 1st months, 3rd months, 6th months
measure: the change of choroidal thickness
timeFrame: baseline, 1st months, 3rd months, 6th months
measure: the change of adjustment range
timeFrame: baseline, 1st months, 3rd months, 6th months
measure: the change of adjust sensitivity
timeFrame: baseline, 1st months, 3rd months, 6th months
Other outcomes:
Locations:
Study officials:
References: