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NCT Number: NCT06088225

Myopia Preventing With Distance-image Screen

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.

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Key information

Age range

6 year–12 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Changes of ocular axial length (mm)

    Time frame: 12-month

    IntraOcularLens (IOL) master biometry will exam each eye before the testing and after the testing with distance-image screen

  2. Changes of refractive error (D)

    Time frame: 12-month

    Cycloplegic refraction with autorefractor will test each eye before the testing and after the testing with distance-image screen

Secondary outcomes

  1. Changes of center macular thickness (um)

    Time frame: 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

  2. Changes of subretina choroidal thickness (um)

    Time frame: 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

  3. Changes of other regions choroidal thickness (um)

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Huadong AI, OD

CONTACT

[email protected]

QIU JENNY, MD

CONTACT

[email protected]

+8618510386815

Sponsors and collaborators

Lead sponsor

Beijing Airdoc Technology Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: DIS

Important dates

Study start
2022
Primary completion
2024
Study completion
2026
First posted
Oct 18, 2023
Registry last updated
Oct 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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