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A Study on the Efficacy and Safety of Two Microstructure Design Lenses in Slowing Myopia Progression: A Parallel, Randomized Controlled Trial

A Study on the Efficacy and Safety of Two Microstructure Design Lenses in Slowing Myopia Progression: A Parallel, Randomized Controlled Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600118456
Enrollment
Unknown
Registered
2026-02-05
Start date
2026-02-15
Completion date
Unknown
Last updated
2026-02-09

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

Conditions

Myopia

Interventions

Group A:H.E.A.L Technology Lens
Group B:H.E.A.L MAX Technology Lens
Control Group:MyoSmart Defocus Incorporated Multiple Segments Lens

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Age >=7 years and =5.0; 4. Willingness to participate in the clinical trial and provision of signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Abnormal intraocular pressure (IOP 21 mmHg); 2. History of intraocular surgery, or history of ocular trauma or external ophthalmic surgery that may interfere with the wearing of spectacle frames; 3. Presence of other ocular diseases or pathological conditions affecting vision or visual function, such as strabismus, keratitis, uveitis, glaucoma, cataract, etc.; 4. Systemic diseases associated with immunosuppression, such as diabetes mellitus, Down syndrome, rheumatoid arthritis, psychiatric disorders, or any other condition deemed by the investigator as unsuitable for spectacle frame wear; 5. Use within the past year of myopia control interventions, including orthokeratology lenses, myopia-control spectacles, red-light therapy devices, defocus soft contact lenses, low-concentration atropine, or distant vision simulation devices; 6. Inability to comply with scheduled ophthalmic examinations; 7.Other conditions deemed by the investigator as exclusion criteria.

Design outcomes

Primary

MeasureTime frame
axial length;

Secondary

MeasureTime frame
Spherical equivalent refractive error measured by autorefraction after cycloplegia;Visual Performance with Eyeglasses;

Countries

China

Contacts

Public ContactYe Yingying

Eye Hospital of Wenzhou Medical University

yeyingying_zoe@163.com+86 188 5778 3288

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 15, 2026