Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Controlling Myopia Progression

NCT ID: NCT05532774

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-12
• Study Completion Date: 2024-11-30

Brief 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. 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ordinary defocusing frame glasses group

wear ordinary defocusing frame glasses

Group Type: NO_INTERVENTION

No interventions assigned to this group

AI defocusing frame glasses group

wear defocusing frame glasses with artificial intelligence

Group Type: EXPERIMENTAL

AI defocusing frame glasses

Intervention Type: DEVICE

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.

Interventions

AI defocusing frame glasses

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.;
• 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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: collaborator

Shandong University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shanghai Eye Disease Prevention and Treatment Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Haidong Zou, MD

Role: STUDY_DIRECTOR

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Locations

Shanghai Eye Diseases Prevention & Treatment Center

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haidong Zou, MD

Role: CONTACT

zouhaidong@sjtu.edu.cn

021-53555032

Xiangui He, PhD

Role: CONTACT

xianhezi@163.com

Facility Contacts

Haidong Zou, M.D.

Role: primary

zouhaidong@sjtu.edu.cn

+86 13311986528

References

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.

Reference Type: BACKGROUND

PMID: 32460315 (View on PubMed)

Other Identifiers

kjb-ljkjj-v1.1-20220814

Identifier Type: -

Identifier Source: org_study_id