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Research on the effect of High Order Phase Element array microstructure lens on myopia control in children

Research on the effect of High Order Phase Element array microstructure lens on myopia control in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087328
Enrollment
Unknown
Registered
2024-07-25
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-29

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

Conditions

Myopia

Interventions

Experimental group 1:HOPE design specification A spectacle
Experimental group 2:HOPE design specification B spectacle
Experimental group 3:HOPE design specification C spectacle

Sponsors

Eye Hospital Affiliated to Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1: Aged 6-12 years; 2: The spherical equivalent refraction of both eyes between -5.00D to -0.75D, astigmatism=1.50D, anisometropia=1.50DD; 3: Best corrected visual acuity =5.0 in both eyes; 4: Subjects and their legal guardians must sign informed consent, be willing to cooperate with treatment and follow-up, and voluntarily participate in this study.

Exclusion criteria

Exclusion criteria: 1: One eye met the inclusion criteria; 2: Systemic diseases that may affect the eyes; 3: Strabismus or binocular visual abnormalities; 4: Abnormal intraocular pressure (the normal intraocular pressure range is 10-21 mmHg, and the difference between eyes should be less than or equal to 5 mmHg); 5: Previous use of optical or pharmaceutical myopia control methods, such as atropine eye drops, orthokeratology, multifocal soft contact lenses, special design spectacle lenses for myopia prevention and control; 6: History of eye surgery or trauma; 7: Participate in clinical trials of other drugs 3 months before screening and clinical trials of other medical devices within 30 days; 8: Unwilling to accept randomization and follow-up; 9: Other conditions in which the investigator judged the patient to be ineligible for inclusion.

Design outcomes

Primary

MeasureTime frame
Axial length;Cycloplegic autorefraction;

Secondary

MeasureTime frame
Best corrected visual acuity;

Countries

China

Contacts

Public ContactBinbin Su

Eye Hospital Affiliated to Wenzhou Medical University

sbb@eye.ac.cn+86 158 6871 7177

Outcome results

None listed

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