The Evaluation of Safety and Myopia Progression Control Using Novel Spectacle Lens
Myopia
About this trial
This is an interventional treatment trial for Myopia
Eligibility Criteria
Inclusion Criteria: Participant and parent (or guardian) are able and willing to provide consent Participant and parent (or guardian) ensure to attend required study visits and adhere to participant requirements Parent or guardian understands and accepts random allocation of grouping, and that participant and parent (or guardian) will not be told which group participant is allocated to Participant willing to wear the study spectacles lens for a minimum of 12 hours per day for the duration of the study Age at time of parent or guardian consent and participant assent: 8 - 13 years old Spherical equivalent cycloplegic autorefraction: -1.00 to -7.00 D in each eye. Cycloplegic autorefraction astigmatism of 1.50 D or less in each eye Cycloplegic autorefraction anisometropia of 1.50 D or less Monocular best corrected distance visual acuity (BCDVA) equal to or better than logMAR 0.00 in each eye. Exclusion Criteria: Participant is allergy to fluorescein, benoxinate, proparacaine, tropicamide or cyclopentolate eye drops Any ocular and systemic abnormalities might be expected to affect visual functions or refractive development Have received treatment of myopic control (e.g., orthokeratology, progressive addition lenses, bifocal lenses, medication (e.g., atropine), etc. within 6 months prior to entry into this study. Participant with clinically significant strabismus (including intermittent tropia) Medical history of binocular vision abnormalities Participant with amblyopia Participation in a clinical trial within 30 days prior to entry into this study or during participation Previous intraocular surgery Participant who, in the judgment of the Investigator, presence of any emotional, physiologic, or anatomical condition which may preclude participation in this study or provide an inappropriate landscape for the intended study treatment. Any medical treatment or medication which might have an influence on vision or interfere with study assessments Pathological myopia (myopia that leads to structural changes in the posterior segment of the eye including posterior staphyloma, myopic maculopathy, and high myopia-associated optic neuropathy)
Sites / Locations
- Beijing Tongren Hospital, Capital Medical UniversityRecruiting
- Guangzhou Aier Eye HospitalRecruiting
- Tianjin Medical University Eye HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Other
Model-A Novel Spectacle lens
Model-B Novel Spectacle lens
Single Vision Spectacle lens