Myopia Preventing With Distance-image Screen

Myopia, Progressive Clinical Trial

— DIS  

Official title:

Clinically Study the Ocular Axial Length and Sphere Equivalence Changes of Children With Distance-image Screen Usage for One Year

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06088225
• Other study ID #: Beijing Airdoc MPC Co., Ltd.
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: December 31, 2026

Study information

• Verified date: October 2023
• Source: Beijing Airdoc Technology Co., Ltd.
• Contact: QIU JENNY, MD
• Phone: +8618510386815
• Email: kkaiqiu[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• 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.

Related Conditions & MeSH terms

• Myopia
• Myopia, Degenerative
• Myopia, Progressive

Intervention

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.

Locations

Country	Name	City	State
China	Airdoc MPC Opthalmology Clinics	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Airdoc Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

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