Clinical trial NCT05532774: Efficacy and Safety of Defocusing Frame Glasses With Artificial Intelligence in Controlling Myopia Progression
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myopia
Lead sponsor: Shanghai Eye Disease Prevention and Treatment Center
Sponsor class: OTHER
Collaborators: name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shandong University of Traditional Chinese Medicine
First posted: 2022-09-08
Enrollment: 138
Sex: ALL
Minimum age (years): 7
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: changes of spherical equivalent
timeFrame: at least 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Eye Diseases Prevention & Treatment Center
state: Shanghai
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Haidong Zou, MD
role: STUDY_DIRECTOR
References:
citation: 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.