Myopia
Conditions
Interventions
HORI trial group:Optical lens: HORI
DOT trial group:Optical lens: DOT
Blank control group:none
Sponsors
Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 8 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria • Subjects must be between 6 and 8 years old (first and second grade) at the time of initial screening. • Subjects and their parents/legal guardians must: - Read the Informed Consent Form - Be fully informed and explained the contents of the consent form - Express understanding of the contents of the consent form - Sign the Informed Consent Form • Understand the nature of this study with parents/legal guardians and be willing to comply with the requirements of this trial • Agree with parents/legal guardians to comply with the procedures of this trial • Agree to wear the assigned frame glasses at least 6 days a week, and wear them for at least 6 hours a day on average. If the wearing schedule needs to be interrupted during the trial, please notify the ophthalmologist and researchers in charge of the trial. If the interruption is due to health factors, the ophthalmologist in charge of the trial can adjust the wearing time according to the situation • Maintain good physical health • The high-contrast naked eye visual acuity of both eyes of the subject is 0.10 logMAR (decimal visual acuity 0.8) or better • After the initial screening and regression formula calculation, the objective diopter of mydriasis (TOPCON computer ophthalmometer) must meet the following standards: - The equivalent spherical power range is -0.50 to +0.75D (inclusive) - Astigmatism = -1.25 D - Anisometropia = 1.00 D
Exclusion criteria
Exclusion criteria: Exclusion criteria • Subjects currently or within 30 days prior to participating in another clinical trial • Previously or currently using any form of myopia control, including but not limited to: • Optical devices - Any type of bifocal/multifocal frame glasses - Any type of bifocal/multifocal contact lenses - Any type of orthokeratology lenses • Medications - Atropine - Pirenzepine • Habitual use of systemic or topical medications that may alter normal eye examination results/are known to affect the subject's eye health/affect the subject's eye health in an adverse or favorable manner and thus affect physiological or contact lens performance/or during participation in a clinical trial • Known allergy to the drugs bupivacaine or oxybuprocaine, sefavirenz, tropicamide eye drops • Manifest strabismus measured by cover test at 3 m away or 40 cm away • Known ocular or systemic diseases, such as but not limited to: - Diabetes mellitus - Graves’ disease - Glaucoma - Uveitis - Scleritis - Autoimmune diseases, such as ankylosing spondylitis, multiple sclerosis, systemic lupus erythematosus • Any ocular, systemic, neurological developmental condition that may affect ocular refractive development, such as but not limited to: - Congenital pupillary remnant - Vitreous hemorrhage - Cataract - Central corneal scar - Eyelid hemangioma - Marfan syndrome - Down syndrome - Albinism - Retinopathy of prematurity • Keratoconus or irregular cornea • The ophthalmologist responsible for the trial may, at their discretion, exclude patients who they believe may not meet the clinical trial requirements or meet the requirements
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Ciliary muscle paralysis computer optometry;Naked eye vision; | — |
Countries
China
Contacts
Public ContactChen Zhi
Fudan University Affiliated Eye, Ear, Nose and Throat Hospital
Outcome results
None listed