Myopia Preventing With Distance-image Screen

Not Applicable

Recruiting

• Conditions: Myopia, Progressive

• 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.

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-12
• Study First Submitted QC: 2023-10-12
• Study First Posted: 2023-10-18
• Last Update Submitted: 2023-10-20
• Last Update Posted: 2023-10-24
• Primary Completion: 2024-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

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