Adolescents and ChildrenNCT05468775
Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
A study testing Naked eye 3D vision training in people with Adolescents and Children and Axial Elongation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Adolescents and Children, Axial Elongation, Naked Eye 3D Vision Training
- What is being tested?
- Naked eye 3D vision training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2022to 1 Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
- Being tested
- Naked eye 3D vision training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Naked eye 3D vision trainingBehavioural
20 minutes of naked eye 3D vision training every day
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Not described Receives: Behavioral: Naked eye 3D vision training |
| control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
the change of axial length
mm
Measured: baseline, 1st months, 3rd months, 6th months
Secondary outcomes (4)
the change of vision
Diopter
Measured: baseline, 1st months, 3rd months, 6th months
the change of choroidal thickness
mm
Measured: baseline, 1st months, 3rd months, 6th months
the change of adjustment range
Diopter
Measured: baseline, 1st months, 3rd months, 6th months
the change of adjust sensitivity
cycle per minute
Measured: baseline, 1st months, 3rd months, 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Aug 2022 (estimated)
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescents and ChildrenStudies of the same condition, open and under way.
- More trials run by Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yehong Zhuo, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468775
- Sponsor's protocol ID
- 2021KYPJ193
- Status last verified
- Jul 2022
- First submitted
- 11 Jul 2022
- Last updated
- 21 Jul 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38587852
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Naked Eye 3D Vision Training for the Prevention and Control of Myopia in Adolescents and Children
- ClinicalTrials.gov ID
- NCT05468775
- Acronym / sponsor ID
- 2021KYPJ193
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Zhongshan Ophthalmic Center, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (estimated)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 21 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Naked eye 3D vision training |
| control group | No intervention | – |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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.;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naked eye 3D vision training20 minutes of naked eye 3D vision training every day | Behavioural | intervention group |
Primary outcome
the change of axial length
Time frame: baseline, 1st months, 3rd months, 6th months
mm
4 secondary outcomes
the change of vision
Time frame: baseline, 1st months, 3rd months, 6th months
the change of choroidal thickness
Time frame: baseline, 1st months, 3rd months, 6th months
the change of adjustment range
Time frame: baseline, 1st months, 3rd months, 6th months
the change of adjust sensitivity
Time frame: baseline, 1st months, 3rd months, 6th months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2022.
- Derived from this study: PubMed 38587852Xie 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Naked eye 3D vision training in people with Adolescents and Children and Axial Elongation, run by Zhongshan Ophthalmic Center, Sun Yat-sen University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the change of axial length (time frame: baseline, 1st months, 3rd months, 6th months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05468775, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2022.