Myopia, Progressive Clinical Trial
— DISOfficial title:
Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year
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.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 6 Years to 12 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Airdoc MPC Opthalmology Clinics | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Beijing Airdoc Technology Co., Ltd. |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 12-month | |
Primary | Changes of refractive error (D) | Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen | 12-month | |
Secondary | 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 | 12-month | |
Secondary | 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 | at 12-month | |
Secondary | 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 | 12-month |
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