Myopia
Conditions
Interventions
DSDO group:Wear flat or low-degree hyperopia, multi-lens partitioned defocal lenses combined with smart glasses frame, 0.9% sodium chloride
control group:Wear a single light flat lens combined with smart glasses frame, 0.9% sodium chloride
DSDOA group:Wear flat or low-degree hyperopia, multi-lens partitioned defocal lenses combined with 0.01% atropine drops
Sponsors
People's Hospital of Peking University
Eligibility
Sex/Gender
All
Age
5 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Aged 5~12 years old; 2. Dilated refraction: spherical power is between +1.00D~0.00D, and astigmatism is less than -1.00D; 3. The best corrected visual acuity of the main refraction monocular can reach 4.9 (0.10LogMAR) and above; 4. The best-corrected visual acuity of each eye after wearing defocus frame lenses was 4.9 (0.10LogMAR) and above; 5. Have normal binocular visual function; 6. Obtain informed consent from family members; 7. At baseline/ Able to learn to wear glasses correctly at the screening visit and voluntarily wear the defocus glasses provided by the trial throughout the study period; 8. Willing to follow the investigator's instructions to use the investigational product and follow the follow-up schedule for follow-up on time.
Exclusion criteria
Exclusion criteria: 1. Anisometropia equivalence of spherical lenses after binocular dilated refraction > 2.00D; 2. The difference in pupil height between the two eyes > 2.0mm; 3. Presence of strabismus and/or amblyopia (examination by occlusion to occlusion test, presence of distant or near-visible squint); 4. History of previous ocular surgery, such as corneal surgery, lens surgery, fundus surgery, etc.; 5. Known allergic reaction or intolerance to any component of Obucaine hydrochloride, topicamide, or cyclopentolate hydrochloride, etc.; 6. Any ocular or systemic disease that may be related to the development of myopia or affect the refractive status of the eye, such as Marfan syndrome, retinopathy of prematurity, etc.; 7. Received myopia prevention and control treatment or visual training within the past 3 months. Includes: progressive frame lenses, peripheral myopia defocus frame lenses, bifocal-frame lenses, defocal design soft hydrophilic contact lenses, or other medications; 8. Received atropine eye drops treatment within the past 12 months; 9. Have received myopia prevention and control treatment or visual training in the past, but the myopia progression is still more than -0.75D per year; 10. Currently participating in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial Length;Diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Choroidal thickness; | — |
Countries
China
Contacts
Public ContactWang Kai
People's Hospital of Peking University
Outcome results
None listed