Myopia, Progressive
Conditions
Keywords
Myopia; children
Brief summary
This study is for testing the efficacy and safety of distance-image screens for preventing myopia in children for 12 month. Each subjects would be asked to paired test the ocular parameters between before and after 12-month distance-image screens.
Detailed description
This study is for testing the efficacy and safety of distance-image screens intended usage for preventing myopia in children with reading after a 6-meter-distant-image device. It was a prospective study. The investigators would like to recruit 100 volunteers, aged 6 years 16 in Beijing. All the volunteers will be complete examined their ocular parameters before using the distant-image screen in a random order for at least 2 hours daily for 12 month. The changes of ocular axial length and refractive error were both calculated before and after 12-month usage for paired t-test.
Interventions
DEVICEdistance-image screen
Distance-image screen is a screen make each image at distance of 6-meters to reduce the accommodation and convergence for eyes during the reading and learning with screens.
Sponsors
Beijing Airdoc Technology Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Paired testing those ocular parameters before and after 12-month usage of distance-image screen
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
Healthy volunteers
Yes
Inclusion criteria
* (1) Must be 6\ 12 years old; * (2) Must be best corrected visual acuity \< logMAR: 0.1; * (3) Spherical Equivalence (SE) must be -1.00\ + 6.00 Diopter (D), * (4) Spherical Equivalence (SE) must have changed \> 1.25 Diopter (D) in the recent 2 years; * (5) Must be astigmatism \<1.75 Diopter (D); * (6) Must be anisometropia \<1.75 Diopter(D).
Exclusion criteria
* (1) Strabismus disease; * (2) Amblyopia disease; * (3) Cataract disease; * (4) Glaucoma disease; * (5) Severe dry eye disease; * (6) Cannot use distance-image screen for 12 month; * (7) Other severe diseases that would effect the use of distance-image screen.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes of ocular axial length (mm) | 12-month | IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen |
| Changes of refractive error (D) | 12-month | Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes of center macular thickness (um) | 12-month | Optic Coherent Topograph (OCT) of macular fovea central thickness will be made to compare the thickness before and after using distance-image screen |
| Changes of subretina choroidal thickness (um) | at 12-month | Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of macular fovea central thickness will be done to compare the thickness before and after using distance-image screen |
| Changes of other regions choroidal thickness (um) | 12-month | Optic Coherent Topograph (OCT) with Enhanced Depth Imaging (EDI) scan of other regions choroidal thickness will be done to compare the thickness before and after using distance-image screen |
Countries
China
Contacts
Primary ContactQIU JENNY, MD
Backup ContactHuadong AI, OD
Outcome results
None listed