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A clinical study to evaluate the effectiveness and safety of Multi-ring defocus plain lens for myopia prevention and control

A clinical study to evaluate the effectiveness and safety of Multi-ring defocus plain lens for myopia prevention and control

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500096438
Enrollment
Unknown
Registered
2025-01-23
Start date
2023-06-01
Completion date
Unknown
Last updated
2025-01-27

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

Conditions

Myopia

Interventions

Control group:No intervention
Test Group:Wear Multizone-Defocus-Plano Spectacles

Sponsors

Changsha Aier Eye Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
7 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1) 2nd grade students in elementary school. 2) Chinese nationality. 3) Equivalent spherical prescription (SER) -3.00D (inclusive) to +3.00D after astigmatism; Equivalent spherical prescription is defined as: spherical prescription + 1/2 column prescription; computerised optometry is performed after 30 minutes of astigmatism. 4) Astigmatism of less than or equal to 1.50D. 5) Refractive index less than or equal to 1.50D. 6) Best corrected visual acuity (BCVA) of not less than 1.0 (0.0 logMAR) in both eyes using a standard logarithmic visual acuity scale. 7) be able to wear lenses when working at close range.

Exclusion criteria

Exclusion criteria: 1) Patients with strabismus. 2) Patients with abnormal stereopsis. 3) Combination of other ocular diseases, including developmental abnormalities affecting visual function and refractive status. 4) A history of previous eye surgery. 5) Previous treatment with other myopia control treatments, including keratoplasty, soft or frame lenses with multifocal design, medication (e.g. atropine), vision training 6) Ongoing application that may affect pupil size and ocular surface function. 7) Combined with other systemic diseases that may affect visual function or refractive status 8) Have a relevant family history of hereditary type of eye disease 9) Other conditions that the investigator considers unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
axial length;Cycloplegic refraction;Equivalent spherical power;

Countries

China

Contacts

Public ContactYang Zhikuan

Changsha Aier Eye Hospital, Aier Eye Hospital Group

13380071988@189.cn+86 133 8007 1988

Outcome results

None listed

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