Myopia Preventing With Distance-image Screen

NCT ID: NCT06088225

Last Updated: 2023-10-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2026-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Myopia, Progressive

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Paired testing those ocular parameters before and after 12-month usage of distance-image screen
Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

distance-image screen

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Beijing Airdoc Technology Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Airdoc MPC Opthalmology Clinics

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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QIU JENNY, MD

Role: CONTACT

+8618510386815

Huadong AI, OD

Role: CONTACT

Facility Contacts

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HUADONG Ai, OD

Role: primary

+8613811449846

QIU JENNY

Role: backup

+8618510386815

Other Identifiers

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Beijing Airdoc MPC Co., Ltd.

Identifier Type: -

Identifier Source: org_study_id

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