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

NCT05532774 | Unknown

• 1 other identifier: kjb-ljkjj-v1.1-20220814
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• changes of spherical equivalent

  Spherical equivalent as measured by cycloplegia autorefraction

  at least 2 years

Study Arms (2)

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

Device: AI defocusing frame glasses

Interventions

AI defocusing frame glasses 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.

AI defocusing frame glasses group

Eligibility Criteria

• Age: 7 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Eye Disease Prevention and Treatment Center: lead
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shandong University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Shanghai Eye Diseases Prevention & Treatment Center

Shanghai, Shanghai Municipality, 200040, China

RECRUITING

Related 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.

  PMID: 32460315 BACKGROUND

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Study Officials

• Haidong Zou, MD

  Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY DIRECTOR

Central Study Contacts

Haidong Zou, MD

CONTACT

021-53555032; zouhaidong@sjtu.edu.cn

Xiangui He, PhD

CONTACT

xianhezi@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 5, 2022
• First Posted: September 8, 2022
• Study Start: September 12, 2022
• Primary Completion: September 12, 2024
• Study Completion: November 30, 2024
• Last Updated: October 4, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)