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Randomized controlled clinical trial for myopia control with disc defocused lens

Randomized controlled clinical trial for myopia control with disc defocused lens

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500095692
Enrollment
Unknown
Registered
2025-01-10
Start date
2024-08-09
Completion date
Unknown
Last updated
2025-01-13

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

Conditions

Myopia

Interventions

Test group A:Wearing DISCmate defocus lens
Control group B:Wearing Hoya DIMS lenses

Sponsors

Tianjin Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
5 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. 5-12 years 2. SER: -1.00 to -5.00 diopter (D) 3. Astigmatism and refractive error <=1.50D 4. Best corrected visual acuity (VA) of 1.0 or better in one eye 5. Acceptance of newly designed lenses 6. Voluntarily participate in this clinical trial and sign the informed consent form;

Exclusion criteria

Exclusion criteria: 1. strabismus and binocular vision abnormalities 2. history of corneal surgery or eye surgery within 1 year; 3. eyelid abnormalities or infections; 4. having other active eye diseases; 5. abnormal intraocular pressure (intraocular pressure 21mmHg or difference in intraocular pressure between both eyes >=5mmHg); 6. Suffering from systemic diseases that may affect the eyes, such as sinusitis, diabetes, Down's syndrome, hyperthyroidism, rheumatoid arthritis, or other diseases that researchers believe preclude the wearing of off-focus framed lenses; 7. Those who require concomitant treatment with therapeutic eye drops, including antibiotics, pupil dilators, corticosteroid hormones and combination eye drops containing corticosteroids; 8. have selected myopia prevention and control measures (e.g., atropine, keratoplasty, defocused lenses) within the past month 9. Those who are judged by the investigator to be ineligible for enrollment.

Design outcomes

Primary

MeasureTime frame
Axial length;

Secondary

MeasureTime frame
Spherical Equivalent refractive error;binocular vision function;

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