Myopia
Conditions
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.
Interventions
DEVICEAI 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.
Sponsors
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Shandong University of Traditional Chinese Medicine
Shanghai Eye Disease Prevention and Treatment Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
7 Years to 14 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| changes of spherical equivalent | at least 2 years | Spherical equivalent as measured by cycloplegia autorefraction |
Countries
China
Contacts
Primary ContactHaidong Zou, MD
Backup ContactXiangui He, PhD
Outcome results
None listed