Myopia Preventing With Distance-image Screen
- Conditions
- Myopia, Progressive
- Interventions
- Device: distance-image screen
- Registration Number
- NCT06088225
- Lead Sponsor
- Beijing Airdoc Technology Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- (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).
- (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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Distance -image screen distance-image screen 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
- Primary Outcome Measures
Name Time Method 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
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
- Secondary Outcome Measures
Name Time Method 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 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 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
Trial Locations
- Locations (1)
Airdoc MPC Opthalmology Clinics
🇨🇳Beijing, Beijing, China