DIS: Myopia Preventing With Distance-image Screen
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 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 |
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.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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(1) Must be 6~12 years old;
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(2) Must be best corrected visual acuity < logMAR: 0.1;
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(3) Spherical Equivalence (SE) must be -1.00~ + 6.00 Diopter (D),
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(4) Spherical Equivalence (SE) must have changed > 1.25 Diopter (D) in the recent 2 years;
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(5) Must be astigmatism <1.75 Diopter (D);
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(6) Must be anisometropia <1.75 Diopter(D).
Exclusion Criteria:
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(1) Strabismus disease;
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(2) Amblyopia disease;
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(3) Cataract disease;
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(4) Glaucoma disease;
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(5) Severe dry eye disease;
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(6) Cannot use distance-image screen for 12 month;
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(7) Other severe diseases that would effect the use of distance-image screen.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Airdoc MPC Opthalmology Clinics | Beijing | Beijing | China | 100089 |
Sponsors and Collaborators
- Beijing Airdoc Technology Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Beijing Airdoc MPC Co., Ltd.