Myopia
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Participants enrolled in the trial must: give informed consent, and have a parent or guardian who is able to read and comprehend Mandarin and give informed consent as demonstrated by signing a record of informed consent by both parent / guardian and the participant; be male or female between 6 and 12 years of age inclusive; be myopic (short-sighted), spherical component -0.75 D to -3.50 D with astigmatism no more than -1.50 D; have at least one parent who is myopic (i.e. a spherical component of at least -0.25D in both eyes); be willing to comply with the wearing and clinical trial visit schedule as directed by the investigator; be willing to wear only the spectacles provided by the investigators; have ocular health findings considered to be "normal"; have vision correctable to at least 6/9.5 or better in each eye with spectacles.
Exclusion criteria
Exclusion criteria: Participants enrolled in the trial must NOT have: 1. a known allergy to, or a history of intolerance to tropicamide or topical anaesthetics; 2. be anisometropic by more than 1.00 D ; 3. astigmatism more than -1.50 D in either eye; 4. had strabismus and/or amblyopia; 5. had previous eye surgery (including strabismus surgery); 6. 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. or had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids; 8. worn bifocals, progressive addition, or MyoVision spectacles in the previous 12 months; 9. worn orthokeratology or bifocal contact lenses in the previous 12 months; 10. current orthoptic treatment or vision training; 11. any anatomical, skin or other condition that would impact on the wearing of spectacles; 12. current enrolment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Myopia progression; | — |
Secondary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Countries
China