Myopia Preventing With Distance-image Screen

NCT06088225 | Recruiting

• 1 other identifier: Beijing Airdoc MPC Co., Ltd.
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Myopia, Progressive

Keywords

Myopia; children

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Changes of center macular thickness (um)

  12-month

• Changes of subretina choroidal thickness (um)

  at 12-month

• Changes of other regions choroidal thickness (um)

  12-month

Study Arms (1)

Distance -image screen

EXPERIMENTAL

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

Interventions

distance-image screen DEVICE

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.

Distance -image screen

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• (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).

You may not qualify if:

• (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.

Sponsors & Collaborators

• Beijing Airdoc Technology Co., Ltd.: lead

Study Sites (1)

Airdoc MPC Opthalmology Clinics

Beijing, Beijing Municipality, 100089, China

RECRUITING

MeSH Terms

Conditions

Myopia, Degenerative; Myopia

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Central Study Contacts

QIU JENNY, MD

CONTACT

+8618510386815; kkaiqiu@126.com

Huadong AI, OD

CONTACT

aihuadong@airdoc.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Paired testing those ocular parameters before and after 12-month usage of distance-image screen

Study Record Dates

• First Submitted: October 12, 2023
• First Posted: October 18, 2023
• Study Start: October 1, 2022
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: October 24, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)