Health TrialsbyHealthPanel

Myopia Preventing With Distance-image Screen

ConditionMyopia, Progressive
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorBeijing Airdoc Technology Co., Ltd.

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

(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;

Disqualifiers

(1) Strabismus disease;

(2) Amblyopia disease;

(3) Cataract disease;

(4) Glaucoma disease;

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

100 Participants
are divided into 1 treatment group
Group A: Distance -image screenExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
12-month
2

Changes of refractive error (D)

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

Time frame
12-month

Secondary outcomes

1

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

Time frame
12-month
2

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

Time frame
at 12-month
3

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

Time frame
12-month

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing Airdoc Technology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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