MyopiaNCT05532774
Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Controlling Myopia Progression
A study testing AI defocusing frame glasses in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
Trial summary
Background: Myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. The number of myopia in China ranks first in the world. Read more about this study
- Who is it for?
- Ages 7 to 14 years
- Conditions the study is for
- Myopia
- What is being tested?
- AI defocusing frame glasses
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteChina
- Study dates
- 12 Sep 2022to 30 Nov 2024
- 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 7 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- The cycloplegic refraction of two eyes is [-0.50D, -5.0D) the astigmatism is ≥ -1.50D; or the cycloplegic refraction of either eye is [-5.00, -10.00D), the astigmatism is ≥ -2.50D;
- Willingness to wear only trial-provided defocusing frame glasses during the trial
- Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- Written informed consent of guardian and child.
Who cannot join
- Allergy or intolerance to cycloplegic drugs;
- The anisometropia is greater than 1.50D;
- Using atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc. for myopia treatment;
- Strabismus/Amblyopia;
- History of eye surgery (including strabismus correction);
- Ocular or systemic diseases that may be related to the development of myopia or myopia: such as Marfan syndrome, neonatal retinopathy, diabetes, etc.;
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- Corneal, conjunctival or eyelid damage or other diseases (keratoconus, herpes simplex keratitis, etc.);
- There are anatomical or skin factors that affect the wearing of spectacles;
- Other circumstances that the investigator judges inappropriate to participate in the trial.
Trial locations and contacts
1 site in 1 country.
Xiangui He, PhD contact
China1 site, 1 recruiting
- Recruiting
Shanghai Eye Diseases Prevention & Treatment Center
Shanghai, Shanghai Municipality, 200040
Haidong Zou, M.D., +86 13311986528, zouhaidong@sjtu.edu.cn
About this study
Official title: Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Children and Adolescents Controlling Myopia Progression: A Multicenter, Randomized, Parallel-Controlled Clinical Trial
Background: Myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. The number of myopia in China ranks first in the world. According to statistics from the National Health and Health Commission, the myopia rate of children and adolescents nationwide in 2020 will be as high as 52.7%. High myopia often leads to permanent visual impairment and even blindness. Retinopathy complicated by high myopia has become the first irreversible blinding eye disease in Shanghai and other regions. The problem is severe. Therefore, it is necessary to actively seek effective myopia treatment and correction methods to slow down the progression of myopia and the excessive extension of the eye axis and reduce the occurrence of complications.
Objective： On the basis of previous research, this study put forward the hypothesis that if behavior management (including outdoor light exposure and close-range eye-use behavior) can be strengthened in children with myopia wearing defocusing frame glasses, it is possible to achieve more effective myopia control effect, thereby not only ensuring safety also effectiveness. A randomized controlled clinical trial is conducted to evaluate the efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression in children and adolescents.
Intervention: Group 1 ( AI defocusing frame glasses group), Group 2 ( Ordinary defocusing frame glasses group). The study period will be 2 years and each participant will be followed up every six month.
- Conditions
- Myopia
- Being tested
- AI defocusing frame glasses
- Medical subject headings
- Myopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AI defocusing frame glassesDevice
AI defocusing frame glasses have the function of eye behavior management, which can delay the progression of myopia through scientific management of eye behavior including outdoor light exposure (≥2 hours/day), duration of continuous close eye use (30 seconds rest every 30 minutes) and close eye distance (one punch, one foot and one inch), etc.
| Study group | Role | What they receive |
|---|---|---|
| Ordinary defocusing frame glasses group | No intervention | wear ordinary defocusing frame glasses |
| AI defocusing frame glasses group | Experimental | wear defocusing frame glasses with artificial intelligence Receives: Device: AI defocusing frame glasses |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of spherical equivalent
Spherical equivalent as measured by cycloplegia autorefraction
Measured: at least 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2022
- Study start12 Sep 2022
- Primary completion12 Sep 2024 (estimated)
- Study completion30 Nov 2024 (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 MyopiaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment Center
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
- Responsible party
- Sponsor
- Investigators
- Haidong Zou, MD, Study director, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05532774
- Sponsor's protocol ID
- kjb-ljkjj-v1.1-20220814
- Status last verified
- Oct 2022
- First submitted
- 5 Sep 2022
- Last updated
- 4 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang HY, Lam CSY, Tang WC, Leung M, To CH. Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):53. doi: 10.1167/iovs.61.5.53.
PubMed 32460315
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Children and Adolescents Controlling Myopia Progression: A Multicenter, Randomized, Parallel-Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05532774
- Acronym / sponsor ID
- kjb-ljkjj-v1.1-20220814
- Conditions
- Myopia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- Shanghai Eye Disease Prevention and Treatment CenterUniversity, hospital or other
- Collaborators
- Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine, Shandong University of Traditional Chinese Medicine
- Study start
- 12 Sep 2022 (actual)
- Primary completion
- 12 Sep 2024 (estimated)
- Study completion
- 30 Nov 2024 (estimated)
- First posted
- 8 Sep 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.
Background: Myopia refers to the pathological state in which the external parallel light enters the eye and focuses in front of the retina, resulting in the inability to clearly image on the retina. The number of myopia in China ranks first in the world. According to statistics from the National Health and Health Commission, the myopia rate of children and adolescents nationwide in 2020 will be as high as 52.7%. High myopia often leads to permanent visual impairment and even blindness. Retinopathy complicated by high myopia has become the first irreversible blinding eye disease in Shanghai and other regions. The problem is severe. Therefore, it is necessary to actively seek effective myopia treatment and correction methods to slow down the progression of myopia and the excessive extension of the eye axis and reduce the occurrence of complications.
Objective： On the basis of previous research, this study put forward the hypothesis that if behavior management (including outdoor light exposure and close-range eye-use behavior) can be strengthened in children with myopia wearing defocusing frame glasses, it is possible to achieve more effective myopia control effect, thereby not only ensuring safety also effectiveness. A randomized controlled clinical trial is conducted to evaluate the efficacy and safety of defocusing frame glasses with artificial intelligence in controlling myopia progression in children and adolescents.
Intervention: Group 1 ( AI defocusing frame glasses group), Group 2 ( Ordinary defocusing frame glasses group). The study period will be 2 years and each participant will be followed up every six month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ordinary defocusing frame glasses group | No intervention | –wear ordinary defocusing frame glasses |
| AI defocusing frame glasses group | Experimental | Device: AI defocusing frame glasseswear defocusing frame glasses with artificial intelligence |
Who may qualify
- Ages
- 7 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The cycloplegic refraction of two eyes is [-0.50D, -5.0D) the astigmatism is ≥ -1.50D; or the cycloplegic refraction of either eye is [-5.00, -10.00D), the astigmatism is ≥ -2.50D;
- Willingness to wear only trial-provided defocusing frame glasses during the trial
- Have normal thinking and language communication skills, and be able to actively cooperate with the treatment as required;
- Written informed consent of guardian and child.
Key exclusion criteria (9 listed)
- Allergy or intolerance to cycloplegic drugs;
- The anisometropia is greater than 1.50D;
- Using atropine, rigid orthokeratology lenses, bifocal lenses or progressive lenses, red light, acupuncture, etc. for myopia treatment;
- Strabismus/Amblyopia;
- History of eye surgery (including strabismus correction);
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 |
|---|---|---|
| AI defocusing frame glassesAI defocusing frame glasses have the function of eye behavior management, which can delay the progression of myopia through scientific management of eye behavior including outdoor light exposure (≥2 hours/day), duration of continuous close eye use (30 seconds rest every 30 minutes) and close eye distance (one punch, one foot and one inch), etc. | Device | AI defocusing frame glasses group |
Primary outcome
changes of spherical equivalent
Time frame: at least 2 years
Spherical equivalent as measured by cycloplegia autorefraction
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2022.
- Background: PubMed 32460315Zhang HY, Lam CSY, Tang WC, Leung M, To CH. Defocus Incorporated Multiple Segments Spectacle Lenses Changed the Relative Peripheral Refraction: A 2-Year Randomized Clinical Trial. Invest Ophthalmol Vis Sci. 2020 May 11;61(5):53. doi: 10.1167/iovs.61.5.53.
- Individual participant dataSharing planned: No
Related trials for Myopia
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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.
Xiangui He, PhD contact
Haidong Zou, MD study director
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI defocusing frame glasses in people with Myopia, run by Shanghai Eye Disease Prevention and Treatment Center at 1 site in China.
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 4 inclusion and 9 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 4 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Contact Haidong Zou, MD (021-53555032, zouhaidong@sjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of spherical equivalent (time frame: at least 2 years). 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 NCT05532774, 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 4 Oct 2022.