Myopia
Conditions
Interventions
Test Group 1:DOT 0.2 + 0.01% atropine once daily
Test Group 2:DOT 0.2 + 0.01% atropine twice daily
Control Group:DOT 0.2 + placebo
Sponsors
Aier Eye Hospital Group Co., Ltd. Changsha Aier Eye Hospital
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Inclusion criteria
Inclusion criteria: 6-13-year-old young myopes. At time of the start of the study, the child must be 6 to 13 years (include 6 and 14 years) of age with -0.75 D to -5.00 D of myopia (SER by cycloplegic autorefraction) in each eye. Best corrected visual acuity (BCVA) by manifest refraction of +0.10 logMAR (0.8 Snellen equivalent) or better in each eye. Agree to wear the assigned study spectacles constantly (including all near-work activities) as well as atropine as assigned except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible. Ability to comply with study procedures in the trial for 18 months, including all assessments of VA, AL, and cycloplegic autorefraction. The subjects (if applicable), and subject's parent(s) or legal guardian(s) must read, understand and sign the ICF and receive a fully executed copy.
Exclusion criteria
Exclusion criteria: Prior usage of multifocal contact lenses, or orthokeratology (ortho-K). Astigmatism is worse than -1.50 DC (by manifest refraction) in either eye. Anisometropia (SER manifest refraction) greater than 1.50 D. Amblyopia in either eye. Strabismus by cover test at far (4 m) or near (40 cm) wearing best correction. Any ocular or systemic conditions that could influence refractive development or status [e.g., keratoconus, congenital glaucoma, ocular trauma, diabetes, Marfan syndrome or other connective tissue disorder, Down syndrome, family history of poor night vision (to prevent enrolling subjects with congenital stationary night blindness). Known allergy to proparacaine, tetracaine, tropicamide, or cyclopentolate. Participation in any investigational clinical study within 30 days before the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length;Cycloplegic refraction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Wide-field retinal refraction ;Choroidal Blood Flow;Choroidal Thickness; | — |
Countries
China
Contacts
Public ContactZhikuan Yang
Changsha Aier Eye Hospital, Aier Eye Hospital Group Co., Ltd.
Outcome results
None listed