Last updated: July 31, 2023
Sponsor: Beijing Airdoc Technology Co., Ltd.
Overall Status: Active - Recruiting
Phase
N/A
Condition
Myopia
Treatment
Photobiomodualtion Therapy
Single vision spectacles for correction myopia
Clinical Study ID
NCT05761379
BeijingAirdoc
Ages 6-16 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Grade 1 to grade 9 and age 6 to 16 years (including 6 and 16 years), Sex is notlimited;
- Equivalent sphere (SER): -0.50D ~ -6.00D (including-0.50 and-6.00D);
- Best corrected vision in one eye under glasses correction: 0.1 log MAR;
- No strabismus: no more than 15 prism constant dominance strabismus after far and nearcover tests;
- No myopia control measures within the previous 4 weeks: such as orthokeratology lens,gradient lens, double light lens, eye drops for myopia control (such as atropine),myopia defocus glasses, red light for myopia control, other specially designed myopialight treatment instruments or contact lenses for special design to control myopia (such as Misight);
Exclusion
Exclusion Criteria:
- Any ocular(including constant dominant strabismus with more than 15 prisms) andsystemic diseases or abnormalities can significantly affect visual function or promotethe progression of myopia;
- Other interventions for myopia control before 4 weeks before enrollment, For example,orthoplastic lens, gradient lens, dual-light lens, eye drops for myopia control (atropine), myopia defocus glasses, red light therapy devices for myopia control,other specially designed comprehensive treatment devices, myopia, amblyopia, orspecially designed contact lenses (such as Misight), etc.
- Subject participated in other clinical trials within 4 weeks before the enrollment;
- The investigator for safety reasons or the interests of the patient, Othercircumstances in which the patient should not participate in this trial, If sufferingfrom serious heart, liver and kidney disease. -
Study Design
Total Participants: 83
Treatment Group(s): 2
Primary Treatment: Photobiomodualtion Therapy
Phase:
Study Start date:
March 28, 2023
Estimated Completion Date:
December 30, 2024
Study Description
Connect with a study center
Eye & ENT hospital of Fudan university
Shanghai, Shanghai 200031
ChinaActive - Recruiting

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