Myopia Preventing With Distance-image Screen (DIS)

Beijing Airdoc Technology

Status: Enrolling

Conditions: Myopia, Progressive

Treatments: Device: distance-image screen

Study type: Interventional

Funder types: Industry

Identifiers

NCT06088225

Beijing Airdoc MPC Co., Ltd.

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 6 to 12 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Distance -image screen

Experimental group

Description:

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

Treatment:

Device: distance-image screen