Myopia
Conditions
Interventions
Test group 1:Two pairs of glasses with different design and phase STOP optical film are required
Change daily for the first month and weekly from the second month.
The optical film was replaced every six months (STOP optical film design and phase change), and the axis and visual acuity and visual
Test group 2:Two pairs of glasses with the same design and phase STOP optical film are required
Change daily for the first month and weekly from the second month.
The optical film was replaced every six months (STOP optical film design and phase were not changed), and the axis and visual acuity
Control group:2 pairs of glasses without structural optical film
Change daily for the first month and weekly from the second month.
The optical film (without structural optical film) was replaced every six months, and the axis and visual acuity and visual quality p
Sponsors
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion criteria • Age 6-14 at entry (including 6 and 14 years) • Subject has: o Read the informed consent, know the contents of the informed consent, express understanding of the contents of the informed consent, and sign the informed consent • Subject's parent/legal guardian has: o Read the informed consent, know the contents of the informed consent, express understanding of the contents of the informed consent, and sign the informed consent • Accompanied by parents/legal guardians who understand the nature of the research and are willing and able to comply with the research requirements. • Agree, along with the parent/legal guardian, to make regular visits and to wear glasses as prescribed by the doctor. • Agree to wear assigned glasses at least 6 days per week for at least 10 hours per day during the study period, and notify the investigator of planned interruptions. • There are wearable glasses with visual functions. • Subject is in good health based on information provided by parent/legal guardian. • Subject will have optimal corrected visual acuity of 0.8 or better in main sense refraction in each eye. • At baseline, each eye meets the following criteria as determined by computerized optometry in cycloplegia: o-4.00D = equivalent spherical lens = -0.75D and spherical lens = -0.50DS o-1.50 DC= astigmatism =0 DC o | equivalent spherical anisometropia |= 1.00D
Exclusion criteria
Exclusion criteria: • The father or mother has more than 600 degrees of myopia • Subject is currently participating in another study or within the 30 days prior to this study. Current or past use of any form of myopia progression control, including but not limited to: o Optical products: Bifocal/multi-focal glasses of any type Any type of bifocal/multi-focal contact lens Any type of orthokeratology o Drugs: Concentration > 0.01% atropine eye drops Participants who have used 0.01% atropine for at least 30 days prior to baseline may participate in this study. 0.01% atropine may not be used during study participation. Pirenzepine • Premature babies born before 30 weeks or birth weight < 1500 grams of subjects. o A verbal inquiry from the subject's parent/legal guardian is sufficient. • Subjects who habitually use systemic or topical drugs that may alter normal ocular examination results in an adverse or beneficial manner/known to affect ocular health/physiology at the time of enrollment and/or during clinical trials. • Subjects who are known to be allergic to sodium fluorescein, obucaine, promecaine, or topicamide. • Subjects determined to be oblique by a long distance (=3 m) or close distance (40 cm) covering test when wearing corrective lenses without cycloplegia. • Known eye or systemic conditions that the investigator determined were not suitable for inclusion, including but not limited to: o Diabetes o Toxic diffuse goiter (also known as Graves' disease) o Glaucoma o Uveitis o Scleritis o Patients with autoimmune diseases such as ankylosing spondylitis, multiple sclerosis, Sjogren's syndrome and systemic lupus erythematosus. Any ocular, systemic, or neurodevelopmental condition that may affect the progression of refraction, including but not limited to: o Persistent pupil membrane o vitreous hemorrhage o Cataract o central corneal scar o Eyelid hemangioma o Marfan syndrome o Down syndrome Ehrles-danlos syndrome o Stickler syndrome o Ocular albinism o Retinopathy of prematurity. • Keratoconus or irregular cornea. • The investigator may, in his or her sole discretion, exclude any person who, in his or her opinion, may not be able to meet the requirements of the clinical trial or who is in the best interest of the subject
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Refractive errors;Axial length;Visual quality parameter;choroid;Periretinal diopter; | — |
Secondary
| Measure | Time frame |
|---|---|
| Accommodation; | — |
Countries
China
Contacts
Public ContactXianli Du
Qingdao Eye Hospital Affiliated to Shandong First Medical University
Outcome results
None listed