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The effects of two single optical signals and their combined design of lenses on the control of childhood myopia: An initial efficacy comparison in a randomized controlled trial and an assessment of the effects after signal switching

The effects of two single optical signals and their combined design of lenses on the control of childhood myopia: An initial efficacy comparison in a randomized controlled trial and an assessment of the effects after signal switching

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600128737
Enrollment
Unknown
Registered
2026-07-24
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-03

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

Conditions

Myopia

Interventions

Group A:Peripheral Diffractive Lenses
Group B:Contrast Reduction Lenses
Group C :Combined Signal Lenses

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1. Myopia degree: 0.00 - -10.00D; astigmatism degree: = 4.9; 3. The patients are aged between 6 and 14 years old, and there is no restriction on gender. 4. Be able to complete at least 24 months of follow-up. 5. Being able to understand the purpose of the experiment, voluntarily participating, and having the informed consent form signed by the subject himself/herself and his/her legal guardian.

Exclusion criteria

Exclusion criteria: 1. History of surgeries that affect eye development; 2. Intraocular pressure > 21 mmHg; 3. Patients with manifest strabismus and amblyopia have significantly abnormal binocular accommodation function. 4. Any single eye with the best corrected visual acuity (VA) less than 4.9; 5. Eye diseases (excluding refractive errors) and systemic diseases of the whole body; 6. Wore myopia prevention lenses, defocus soft lenses, or used low-concentration atropine eye drops within one month; 7. Worn OK lenses or other methods for correcting myopia within the past 3 months (such as red light-related treatment methods); 8. History of systemic medication (drugs that affect growth and development, such as growth hormone); 9. Currently participating in any clinical research trials for myopia control; 10. Other circumstances that the researchers consider unsuitable for participating in the trial.

Design outcomes

Primary

MeasureTime frame
change in axial length during 12 months;

Secondary

MeasureTime frame
Contrast sensitivity;change in refraction;Axial length of the eye;Choroidal thickness;Genetic testing;

Countries

China

Contacts

Public ContactChen Ruru

Eye Hospital, Wenzhou Medical University

251517129@qq.com+86 138 6805 1650

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 10, 2026