Myopia
Conditions
Interventions
Test Group:Wear test lenses daily, for at least 12 hours/day and 7 days/week, expected to last for 24 months
Control Group:Wear control lenses daily, for at least 12 hours/day and 7 days/week, expected to last for 12 months
From 12-month to 24-month, participants originally wearing control lenses will switch to wear test lenses daily, for 12 hours/day and 7 days/week.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat sen University
Eligibility
Sex/Gender
All
Age
6 Years to 12 Years
Inclusion criteria
Inclusion criteria: 1.Volunteer participant. 2.Informed consent of parent/guardian and assent of participant. 3.Age equal to or greater than 6 years and not older than 12 years at the time of signing informed consent and assent. 4.SER by cycloplegic autorefraction equal or less than -0.50 D and equal or greater than -4.75 D with astigmatism not more than 2.00 D. 5.Difference in SER (anisometropia) between two eyes should not exceed 1.00 D. 6.Best corrected visual acuity (BCVA) better than or equal to +0.10 LogMAR in each eye. 7.Be in good general health, based on the participant and the parent’s/guardian’s knowledge. 8.Agree to wear spectacles for 12 hours/day and 7 days/week. 9.Willingness and ability to participate in study and comply with all scheduled visits. 10.Agree not to be involved in other myopia control treatments.
Exclusion criteria
Exclusion criteria: 1.History of myopia control intervention (e.g. atropine, orthokeratology, multifocal contact lenses, spectacle lenses etc.). 2.Strabismus by cover test at near or distance wearing correction. 3.Amblyopia. 4.Any ocular or systemic condition known to affect refractive status (e.g. keratoconus, diabetes, Downs syndrome, or other developmental disorders, etc.). 5.Current use of ocular or systemic medications which, in the investigator’s opinion, may significantly affect pupil size, accommodation or refractive state. 6.Current or anticipated use of growth hormones. 7.Participation in any clinical study within 30 days of the Baseline visit. 8.Study participants deemed inappropriate for the study by the investigator. 9.Siblings of current participants in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in cycloplegic objective spherical equivalent refraction (SER) from baseline to 12 months;Mean change in Axial Length (AL) from baseline to 12 months; | — |
Countries
China
Contacts
Public ContactYang Xiao
Zhongshan Ophthalmic Center, Sun Yat sen University
Outcome results
None listed