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Study on the safety and effectiveness of myopia and amblyopia comprehensive therapeutic instrument for controlling myopia progression in children and adolescents

Study on the safety and effectiveness of myopia and amblyopia comprehensive therapeutic instrument for controlling myopia progression in children and adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066365
Enrollment
Unknown
Registered
2022-12-02
Start date
2022-12-08
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

Experimental Group:Wear myopic frame glasses (optical monocal lens) +BBL myopia amblyopia comprehensive treatment instrument
Control group:Wear myopic frame glasses (optical monocal lens)

Sponsors

Eye Hospital, WMU Zhejiang Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Age at enrollment ranged from 8 to 12 years, both sexes; 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 in both eyes -- 0.75D=SE < -6.00D; Anisometropia & LT; 4. 1.5 D; 5. Monocular international standard logarithmic visual acuity =5.0 after glasses correction; 6. No other organic lesions affecting vision in both eyes; 7. Subjects and guardians can understand the purpose of this trial and sign the informed consent. Subjects can cooperate with the treatment and related ophthalmic examination.

Exclusion criteria

Exclusion criteria: 1. Strabismus and/or amblyopia; 2. The deviation exceeds ±5 circumferential degree (1 circumferential degree =1.75 prism degree); 3. Astigmatism greater than 2.50D; 4. Previous eye surgery (including strabismus surgery); Congenital color vision disorder (color blindness); 5. 6. Any ocular, systemic or other diseases that may be related to myopia or affect refractive development, such as Marfan syndrome, retinopathy of prematurity, diabetes mellitus; 7. Any eye injury or corneal, conjunctival or eyelid disease (including keratoconus and herpetic keratitis), fundus lesions; 8. Worn bifocal glasses, progressive glasses, orthokeratology glasses, bifocal contact lenses or other functional lenses within 3 months; 9. Orthopaedic therapy or vision training is currently under way; 10. Had used atropine ophthalmic medicine in the past 3 months; 11. Photophobia or inability to open eyes properly; 12. Any physiological structure, skin or other condition that may affect the wearing of glasses; 13. Participated in other clinical trials 4 weeks before enrollment; 14. The subject has an acute or chronic disease (including other existing acute or chronic pain) or mental illness, which may increase the risk associated with participating in the study or using the investigational products or may affect the interpretation of the study results, and in the judgment of the investigator or a medically qualified designee, These conditions make the subjects unsuitable for enrollment in this study.

Design outcomes

Primary

MeasureTime frame
Axial length;

Secondary

MeasureTime frame
Spherical equivalent;Choroidal thickness;

Countries

China

Contacts

Public ContactQu Jia

Eye Hospital, WMU Zhejiang Eye Hospital

13806898805@163.com13806898805

Outcome results

None listed

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