Myopia
Conditions
Interventions
Control Group:Single vision lenses (Mingyue Lens Co., Ltd.)
Experimental Group:Optically optimized lenses (Mingyue Lens Co., Ltd.)
Sponsors
Henan Provincial Eye Hospital
Eligibility
Sex/Gender
All
Age
8 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Aged 8 to 14 years (inclusive of 8 and 14 years old), gender unrestricted. 2. Meet the diagnostic criteria for simple myopia, with a spherical equivalent refraction between -0.75 D and -6.00 D (inclusive), and astigmatism = 1.0 in both eyes. 4. Intraocular pressure (IOP) < 21 mmHg in both eyes. 5. Willing to participate in the trial for one year without wearing other types of lenses. 6. Understand the trial objectives and voluntarily agree to participate by signing the informed consent form (For minors under 18 years of age, consent must be obtained from both the participant and their guardian, with corresponding signatures on the informed consent form).
Exclusion criteria
Exclusion criteria: 1. Patients who use contact lenses. 2. Patients with a history of myopia control treatment within the past 3 months or those planning to undergo such treatment during the clinical study period. 3. Patients with any known active ocular disease and/or infection. 4. Patients with amblyopia in either eye or any other known binocular vision disorder, such as accommodative insufficiency. 5. Patients with a history of systemic diseases that cause immunodeficiency (e.g., acute or chronic sinusitis, diabetes, Down syndrome, rheumatoid arthritis, psychiatric disorders, or any other condition deemed by the investigator as unsuitable for wearing spectacles). 6. Patients who have undergone strabismus surgery, refractive surgery, or intraocular surgery. 7. Patients who have previously participated in other drug or medical device clinical trials and have not reached the study endpoint within one month prior to screening. 8. Patients unable to comply with the scheduled follow-up visits. 9. Patients considered by the investigator to be unsuitable for participation in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial Length ;Adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Uncorrected Visual Acuity (UVA) ; Best-Corrected Visual Acuity (BCVA) ;Cycloplegic Objective Refraction (including refractive error) Cycloplegic;Corneal Curvature / Keratometry ;Evaluation of wearing comfort; | — |
Countries
China
Contacts
Public ContactTianbin Lyu
Henan Provincial Eye Hospital (Affiliated to Henan Provincial People‘s Hospital)
Outcome results
None listed