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A clinical trial to evaluate the safety and effectiveness of the myopia and amblyopia comprehensive treatment instrument for adjuvant therapy and control the development of mild to moderate myopia in children and adolescents

A clinical trial to evaluate the safety and effectiveness of the myopia and amblyopia comprehensive treatment instrument for adjuvant therapy and control the development of mild to moderate myopia in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200067069
Enrollment
Unknown
Registered
2022-12-26
Start date
2023-01-01
Completion date
Unknown
Last updated
2023-05-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myopia

Interventions

Test group 1:Wearing myopia frame glasses (optical monofocal lenses)+BBL myopia and amblyopia comprehensive treatment instrument red light feeding treatment+BBL myopia and amblyopia treatment instrume
Test group 2:Wearing myopia frame glasses (optical monofocal lenses)+BBL myopia and amblyopia comprehensive treatment instrument red light feeding treatment
Control group:Wearing myopia frame glasses (optical monofocal lenses)

Sponsors

The First Affiliated Hospital with Nanjing Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: (1)Age 8~15 years old, gender is not limited; (2)The patient was diagnosed as nearsighted according to the Guidelines for Prevention and Treatment of Myopia issued by the General Office of the National Health Commission (Medical Letter [2018] No. 393); (3)Optometry after cycloplegia -6.00D<equivalent spherical lens=-0.75D; (4)Anisometropia <1.5D, and astigmatism =2.5D; (5)The best corrected visual acuity in both eyes = 1.0; (6)Willing to wear uniformly issued frame glasses; (7)Able to actively cooperate with training and review regularly; (8)Understand the purpose of this experiment and participate voluntarily, and the person or guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: (1)There are organic lesions affecting visual function in both eyes. (2)photosensitivity; or photophobia. (3)combined strabismus. (4)congenital color vision disorder. (5)Eye surgery (including strabismus surgery) within the past six months. (6)Have worn bifocals, progressive glasses, orthokeratology lenses, bifocal contact lenses, or other functional lenses within 3 months. (7)Previous or current use of atropine eye drops for myopia control. (8)Combined with ocular, systemic or other diseases that may be related to pathological myopia or affect refractive development, such as Marfan syndrome, retinopathy of prematurity, diabetes. (9)Patients who are taking drugs that may affect pupil size, accommodation, or have effects on the ocular surface (eg, atropine, antiallergic drugs). (10)Those who are participating in other clinical trials. (11)Others may increase the risks associated with participating in the research or using experimental products, or may affect the interpretation of the research results, and the researchers judge that they are not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Axial Length (AL);

Secondary

MeasureTime frame
Best Corrected Visual Acuity ;Spherical Equivalent;

Countries

China

Contacts

Public ContactLiu Hu

The First Affiliated Hospital with Nanjing Medical University

liuhu66@163.com13952091066

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026