Myopia control in myopic children Eye Diseases
Conditions
Interventions
The purpose of this study is to compare the ‘visual performance’ of the three myopia control spectacle lenses (DOT, DIMS, CARE) and their habitual single vision spectacles. Participants will use all
Sponsors
SightGlass Vision
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Myopic children aged 6 to 14 years, with spherical equivalent refraction (SER) -0.75 D to -4.00 D (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. Pass stereopsis and color vision screening. 4. Ability to comply with all study procedures, including assessments of visual performance with assigned correction. 5. Willingness to wear assigned spectacles for the duration of the study. 6. The 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 use of any myopia control approaches, such as atropine, multifocal contact lenses, orthokeratology (ortho-K), or other spectacle lenses designed for myopia control including peripheral defocus, bifocal, and progressive addition lenses. 2. Astigmatism worse than -1.25 DC (by manifest refraction) in either eye. 3. Anisometropia (SER manifest refraction) greater than 1.00 D. 4. Amblyopia in either eye. 5. Strabismus by cover test at far (4 m) or near (40 cm) wearing distance correction. 6. 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). 7. Participation in any investigational clinical study within 30 days of the Screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual performance measured using Aston Vision iPad App (visual acuity, reading speed, near contrast sensitivity, and halometry) of test spectacles at baseline and after 1-2 weeks of wear in comparison with habitual spectacles. 1. Visual acuity in logMAR (number of letters read on the letter chart) 2. Reading speed in maximum words per minute 3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) 4. Halometry in halo radius in degrees | — |
Secondary
| Measure | Time frame |
|---|---|
| Visual performance measured using Aston Vision iPad App at baseline and after 1-2 weeks of wear with 3 different test spectacles: 1. Visual acuity in logMAR (number of letters read on the letter chart) 2. Reading speed in maximum words per minute 3. Near contrast sensitivity at @ 1.5, 3.0, 6.0, 12.0 and 18.0 cycles per degree (cpd) 4. Halometry in halo radius in degrees | — |
Countries
China
Outcome results
None listed