Myopia
Conditions
Interventions
1:Commercially-available,spherical-profile spectacle lenses to be worn all waking hours.
2:Commercially-available aspheric front surface spectacle lenses to be worn all waking hours.
Sponsors
Zhongshan Ophthalmic Center
Eligibility
Sex/Gender
All
Age
7 Years to 14 Years
Inclusion criteria
Inclusion criteria: 1. Have a parent or guardian who is able to read and comprehend Mandarin and who gives informed consent as demonstrated by signing a record of Informed Consent by parent / guardian, and the subject if able to give their own consent; 2. Be ethnic Chinese, male or female, 7 to 14 years of age inclusive; 3. Be myopic (short-sighted) -0.50 D minimum spherical component to -3.50 D spherical equivalent, with astigmatism no more than 0.75 D; 4. Be willing to comply with the wearing and clinical trial visit schedule as directed by the Investigator; 5. Be willing to wear only the spectacles provided by the Investigators; 6. Have ocular health findings considered to be “normal”;7. Have best correctable vision of at least 6/9.5 in each eye.
Exclusion criteria
Exclusion criteria: 1. Have a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 2. Be anisometropic by more than 1.50 D; 3. Have undergone atropine treatment for myopia control; 4. Have strabismus and/or amblyopia; 5. Have had previous eye surgery (including strabismus surgery); 6. Have any ocular, systemic or other condition or disease with possible associations with myopia or affecting refractive development e.g. Marfan syndrome, retinopathy of prematurity, diabetes; 7. Have had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids; 8. Have worn bifocal or progressive addition spectacles in the previous 12 months; 9. Have worn orthokeratology contact lenses in the previous 12 months; 10. Current orthoptic treatment or vision training; 11. Have any anatomical, skin or other condition that would impact on the wearing of spectacles; 12. Be currently enrolled in another clinical trial. The Investigator may, at his/her discretion, exclude anyone else who they believe may not be able to fulfil the study requirements, or if it is believed to be in the subject's best interests.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Change in spherical equivalent refraction and axial length from baseline levels lenses in children; | — |
Primary
| Measure | Time frame |
|---|---|
| Change in spherical equivalent refraction and axial length from baseline levels; | — |
Countries
China
Contacts
Public ContactXiang Chen
Outcome results
None listed