An interventional study of distance-image screen in Myopia, Progressive, sponsored by Beijing Airdoc Technology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 6 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-24.
Sponsored by Beijing Airdoc Technology Co., Ltd. · Not applicable, Interventional, and Prevention
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.
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.
984 studies on the registry are indexed under Myopia; 210 are open to participants now.
This study's planned enrollment of 100 is above the median of 80 across 783 interventional studies indexed under Myopia.
Browse Myopia studies →Beijing Airdoc Technology Co., Ltd. is the lead sponsor of 8 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Distance -image screen is a device to make image in the distance of 6-meters when reading and learning at near. The investigators will ask the subjects to use the distance - image screen for 12 month
Device: distance-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.
Changes of ocular axial length (mm)
IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen
Time frame: 12-month
Changes of refractive error (D)
Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen
Time frame: 12-month
Changes of center macular thickness (um)
Optic Coherent Topograph (OCT) of macular fovea central thickness will be made to compare the thickness before and after using distance-image screen
Time frame: 12-month
Changes of subretina choroidal thickness (um)
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
Time frame: at 12-month
Changes of other regions choroidal thickness (um)
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
Time frame: 12-month
Plan to share: No
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Beijing Airdoc Technology Co., Ltd.