Refractive error
Conditions
Interventions
Experimental Group A:Wearing multi-focal high astigmatism type I lenses (5.50D)
Experimental Group B:Combined Type II lens (DOT additional transparent multifocal micro lens (5.50D) lens)
Control group:Wearing TAG Heuer New Learning Lenses
Sponsors
Shanghai Eye Disease Prevention & Treatment Center/Shanghai Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1. Age 6 to 12 years old (including 6 and 12 years old), gender is not limited. 2. Myopia equivalent spherical lenscopy is -0.50D to -6.00D or above (including -0.50D and -6.00D, subject to computer automatic refraction under cycloplegia). 3. Astigmatism was between 0.00D and -1.50D (including 0.00D and -1.50D) at the time of enrollment, and the difference in anisometric refraction between the two eyes after the equivalent spherical mirror was less than or equal to 1.50D. 4. The best corrected visual acuity of the subjective refraction monocular can reach 5.0 (0.00LogMAR) and above. 5. The best corrected visual acuity in one eye after wearing myopia defocus glasses is 5.0 (0.00LogMAR) or above. 6. Accompanied by a parent or guardian, and the parent or guardian can read and understand the content of the informed consent form, and voluntarily sign the informed consent form with the child himself. 7. Able to learn to wear glasses correctly at the baseline/screening visit and voluntarily wear myopia defocus glasses provided by the trial throughout the study period. 8. Accept the randomization process, be willing to follow the guidance of the investigator to use the investigational product, and follow the follow-up schedule on time.
Exclusion criteria
Exclusion criteria: 1. Clinically meaningful slit lamp examination findings as judged by the investigator. 2. Presence of strabismus and/or amblyopia (to mask to de-mask test examination, presence of farsightedness or near strabismus) 3. History of previous ocular surgery, such as corneal surgery, lens surgery, fundus surgery, etc. 4. Known allergic reaction or intolerance to any of the ingredients such as obucaine hydrochloride, topicamide or cyclopentobell hydrochloride. 5. Have any ocular or systemic diseases 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. 6. Received myopia prevention and control treatment or visual training within the past 1 month. These include: orthokeratology, progressive frame lenses, peripheral myopia defocus frame lenses, bifocal frame lenses, soft hydrophilic contact lenses with defocus design, or other drug treatments. 7. Currently participating in another clinical trial. 8. Only one eye meets the selection criteria; 9. Other situations that the investigator judges are not suitable for inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length changes compared to baseline ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in axial length compared to baseline ;The change in the equivalent spherical power of objective refraction after ciliary muscle paralysis compared to the baseline.;Changes in the optical cylinder power measured objectively, relative to the baseline.;The change in binocular visual function of the subjects from baseline;The changes in choroidal thickness and blood flow from baseline in subjects; | — |
Countries
China
Contacts
Public ContactZhu Mengjun
Shanghai Eye Disease Prevention & Treatment Center/Shanghai Eye Hospital
Outcome results
None listed