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Myopia Preventing With Distance-image Screen

Recruiting
6 - 12 years of age
Both
Phase N/A

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Overview

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.

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.

Eligibility

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 details

Myopia, Progressive

NCT06088225

Beijing Airdoc Technology Co., Ltd.

25 January 2024

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