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Evaluation of the safety, efficacy, and adaptability of defocus lenses for vision correction and myopia prevention and control

Evaluation of the safety, efficacy, and adaptability of defocus lenses for vision correction and myopia prevention and control

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114742
Enrollment
Unknown
Registered
2025-12-17
Start date
2025-06-18
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

Myopia

Interventions

Experimental Group A:Wearing IBrightB defocus lens
Experimental Group B:Wearing IBrightM defocus lens

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. 8 -13 years old 2. SER: -0.75D and -5.00D (including-0.75D and -5.00D) in both eyes; astigmatism <=1.50D, refractive error <=1.50D 3. Best-corrected visual acuity in one eye of 0.0 LogMAR or better 4. Ability to comply with the requirements for spectacle wear (at least 10 hours per day) during the study; 5. Patients and their guardians were willing to complete the interviews

Exclusion criteria

Exclusion criteria: 1. Premature infants (earlier than 30 weeks or <1500 g); 2. Products that have been used or are being used within one month to slow myopia progression, such as specially designed myopia-control lenses, and atropine-type medications; 3. Ocular and systemic anomalies that may affect visual function or refractive development, and that in the judgment of the investigator are not appropriate for wear; 4. Patients who are using or need to use drugs that may cause dry eyes or affect vision during the follow-up study (e.g., penicillin, streptomycin, chloramphenicol, sulfonamides, isoniazid, etc.); 5. Known allergy to oxybutynin, proparacaine, or tropicamide; 6. Conspicuous strabismus or obvious binocular visual anomalies; 7. Concurrent participation in other clinical trials

Design outcomes

Primary

MeasureTime frame
Axial length;Binocular vision function;Eye movement;

Countries

China

Contacts

Public ContactLi Lihua

Tianjin Eye Hospital

tysgzxlccs@163.com+86 156 9224 5330

Outcome results

None listed

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