Back to resultsNaked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
Primary Purpose
Adolescents and Children, Axial Elongation, Naked Eye 3D Vision Training
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Naked eye 3D vision training
Sponsored by
About this trial
This is an interventional prevention trial for Adolescents and Children
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
intervention group
control group
Arm Description
Outcomes
Primary Outcome Measures
the change of axial length
mm
Secondary Outcome Measures
the change of vision
Diopter
the change of choroidal thickness
mm
the change of adjustment range
Diopter
the change of adjust sensitivity
cycle per minute
Full Information
NCT ID
NCT05468775
First Posted
July 11, 2022
Last Updated
July 18, 2022
Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
1. Study Identification
Unique Protocol Identification Number
NCT05468775
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2022 (Anticipated)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
October 1, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zhongshan Ophthalmic Center, Sun Yat-sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescents and Children, Axial Elongation, Naked Eye 3D Vision Training, Visual Function
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Naked eye 3D vision training
Intervention Description
20 minutes of naked eye 3D vision training every day
Primary Outcome Measure Information:
Title
the change of axial length
Description
mm
Time Frame
baseline, 1st months, 3rd months, 6th months
Secondary Outcome Measure Information:
Title
the change of vision
Description
Diopter
Time Frame
baseline, 1st months, 3rd months, 6th months
Title
the change of choroidal thickness
Description
mm
Time Frame
baseline, 1st months, 3rd months, 6th months
Title
the change of adjustment range
Description
Diopter
Time Frame
baseline, 1st months, 3rd months, 6th months
Title
the change of adjust sensitivity
Description
cycle per minute
Time Frame
baseline, 1st months, 3rd months, 6th months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
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