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To observe the clinical effect of rotationally symmetric design combined with micro lens array design optical lens on myopia delay and myopia prevention in adolescents

To observe the clinical effect of rotationally symmetric design combined with micro lens array design optical lens on myopia delay and myopia prevention in adolescents

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078464
Enrollment
Unknown
Registered
2023-12-08
Start date
2023-06-23
Completion date
Unknown
Last updated
2023-12-10

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

Conditions

Myopia

Interventions

RSMA hyperopia group:Wearing rotationally symmetric design combined with micro lens array lens
SVL hyperopia group:Wear single vision lens
RSMA myopia group:Wearing rotationally symmetric design combined with micro lens array lens
MLA myopia group:Wearing micro lens array lens
SVL myopia group:Wearing single vision lens

Sponsors

Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Adolescents, aged 6 to 12 years; 2. Binocular diopters (after cycloplegic computer refraction) : Part 1: -0.50 to -4.50D (including -0.50D and -4.50D); Part 2: +2.00 ~-0.50 (not including -0.50D, including +2.00D) 3. Astigmatism =-1.50D; 4. Willing to wear glasses and willing to undergo randomization 5. Cooperate with the follow-up review time and the examination partners

Exclusion criteria

Exclusion criteria: 1. Intraocular pressure > 21mmhg 2. Those with obvious inclinations; 3. Binocular accommodation dysfunction; 4. The best corrected visual acuity (VA) of any eye was less than 4.9; 5. Eye diseases (except ametropia) and systemic diseases affecting visual development; 6. History of ocular or systemic surgery affecting eye development; 7. Wearing defocus lenses or using low concentration atropine eye drops within 3 months; Wearing OK lenses or other myopia interventions (e.g., red light-related treatments) within 6 months 8. History of systemic medication (drugs that affect growth and development, such as growth hormone) 9. Currently participating in any myopia control clinical research trial 10. Any other circumstances deemed by the investigator to be inappropriate for trial participation

Design outcomes

Primary

MeasureTime frame
Refraction;Axial length;

Secondary

MeasureTime frame
Choroidal blood flow;

Countries

China

Contacts

Public ContactJin Wanqing

The Eye Hospital of Wenzhou Medical University

924923394@qq.com+86 152 6779 4560

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Apr 28, 2026