Myopia
Conditions
Interventions
1:wearing intermittently spectacles fitted with concentric bifocals lens and single-vision lens
2:wearing spectacles fitted with traditional single-vision lens
Sponsors
Zhongshan Ophthalmic Center
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: Participants enrolled in the trial must: 1. 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; 2. be male or female between 6 and 12 years of age inclusive; 3. be myopic (short-sighted), spherical component -0.75 D to -3.50 D with astigmatism no more than -1.50 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 vision correctable to at least 6/9.5 or better in each eye with spectacles.
Exclusion criteria
Exclusion criteria: 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. had strabismus and/or amblyopia; 4. had previous eye surgery (including strabismus surgery); 5. 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; 6. had any ocular injury or condition (including keratoconus and herpes keratitis) of the cornea, conjunctiva or eyelids; 7. worn bifocals or progressive addition spectacles; 8. worn orthokeratology or bifocal contact lenses; 9. current orthoptic treatment or vision training; 10. any anatomical, skin or other condition that would impact on the wearing of spectacles; 11. current enrolment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the change in spherical equivalent myopia from baseline values;the increase in ocular axial length from baseline values; | — |
Countries
China
Contacts
Public ContactXiang Chen
Outcome results
None listed