Myopia Preventing With Distance-image Screen (DIS)

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia, Progressive
• Intervention / Treatment: Device: distance-image screen

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: QIU JENNY, MD; Phone Number: +8618510386815; Email: kkaiqiu@126.com
• Study Contact Backup: Name: Huadong AI, OD; Email: aihuadong@airdoc.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100089
      • Recruiting
      • Airdoc MPC Opthalmology Clinics
      • Contact: HUADONG Ai, OD; Phone Number: +8613811449846; Email: drqiu666@126.com
      • Contact: QIU JENNY; Phone Number: +8618510386815; Email: kkaiqiu@126.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Distance -image screen; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: Beijing Airdoc Technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: October 12, 2023
• First Submitted That Met QC Criteria: October 12, 2023
• First Posted (Actual): October 18, 2023

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 20, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Myopia; children
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Myopia, Degenerative
• Other Study ID Numbers: Beijing Airdoc MPC Co., Ltd.

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No