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

Myopia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05532774
• Other study ID #: kjb-ljkjj-v1.1-20220814
• Status: Recruiting
• Phase: N/A
• Start date: September 12, 2022
• Est. completion date: November 30, 2024

Study information

• Verified date: October 2022
• Source: Shanghai Eye Disease Prevention and Treatment Center
• Contact: Haidong Zou, MD
• Phone: 021-53555032
• Email: zouhaidong[@]sjtu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: November 30, 2024
• Est. primary completion date: September 12, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 14 Years

Eligibility

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.

Related Conditions & MeSH terms

• Myopia

Intervention

Device:
• 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.

Locations

Country	Name	City	State
China	Shanghai Eye Diseases Prevention & Treatment Center	Shanghai	Shanghai

Sponsors (3)

Lead Sponsor	Collaborator
Shanghai Eye Disease Prevention and Treatment Center	Shandong University of Traditional Chinese Medicine, Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	changes of spherical equivalent	Spherical equivalent as measured by cycloplegia autorefraction	at least 2 years