myopia
Conditions
Interventions
Experimental group:DOT 0.2 spectacle
Control group:Control spectacle
Sponsors
Eye & ENT Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
6 Years to 13 Years
Inclusion criteria
Inclusion criteria: 1. At time of the start of the study, child must be 6 to 13 years (include 6 and 13 years) of age with -0.75 D to -5.00 D of myopia (SER by cycloplegic autorefraction) in each eye 2. Best corrected visual acuity (BCVA) by manifest refraction of +0.10 logMAR (0.8 Snellen equivalent) or better in each eye 3. Agree to wear the assigned study spectacles constantly (including all near-work activities) except for sleeping, swimming, or other activities in which spectacle wear would be dangerous or otherwise not possible 4. Ability to comply with study procedures, including assessments of visual acuity (VA), AL, and cycloplegic autorefraction 5. Willingness to wear study spectacles and participate in the trial for 12 months without contact lens wear 6. 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: 1. Prior usage of atropine, multifocal contact lenses, or orthokeratology (ortho-K) 2. Usage of spectacle lenses designed for myopia control including peripheral defocus, bifocal, and progressive addition lenses within 30 days prior to the screening visit 3. Astigmatism worse than -1.50 DC (by manifest refraction) in either eye 4. Anisometropia (SER manifest refraction) greater than 1.00 D 5. Amblyopia in either eye 6. Strabismus by cover test at far (4 m) or near (40 cm) wearing best correction 7. 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 against enrolling subjects with congenital stationary night blindness)] 8. Known allergy to proparacaine, tetracaine, tropicamide, or cyclopentolate 9. Participation in any investigational clinical study within 30 days before the Screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Axial length; | — |
Secondary
| Measure | Time frame |
|---|---|
| Spherical equivalent; | — |
Countries
China
Contacts
Public ContactZhi Chen
Eye & ENT Hospital, Fudan University
Outcome results
None listed