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A multicenter, randomized controlled clinical trial evaluating the efficacy and safety of four different types of microstructure lenses in delaying the progression of myopia

A multicenter, randomized controlled clinical trial evaluating the efficacy and safety of four different types of microstructure lenses in delaying the progression of myopia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2600129355
Enrollment
Unknown
Registered
2026-08-04
Start date
2026-08-10
Completion date
Unknown
Last updated
2026-08-10

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

Conditions

Myopia

Interventions

Test Group C:Contrast-reducing design lenses
Control group D group:Single Microlens Design Lens (HAL lens)
Test Group B:Two types of microstructure-designed lenses
Test Group A:Three types of microstructure-designed lenses

Sponsors

Eye Hospital, Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Ages 6-12 years old. Consent from the guardian is required in writing. Gender is not restricted; 2. Under dilated eyes, the objective refraction spherical power values were all within the range of -0.50D (inclusive) to -4.50D (inclusive) (based on the average value of the objective refraction examination); and the refractive anisometropia of both eyes after converting to equivalent spherical power was <=1.50D; 3. Astigmatism is less than or equal to 1.50D; 4. Voluntarily participate in this clinical trial, cooperate with the examinations, and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Abnormal intraocular pressure (intraocular pressure 21 mmHg or intraocular pressure difference between both eyes >= 5 mmHg); 2. Oblique individuals; 3. There is a significant abnormality in the function of the eyes' accommodation. 4. Any single eye with the best corrected visual acuity (VA) less than 4.9; 5. Eye diseases that affect visual development (excluding refractive errors) and systemic diseases of the whole body; 6. History of eye or systemic surgeries that affect eye development; 7. Wore orthokeratology lenses, astigmatic soft contact lenses, or used low-concentration atropine eye drops within 1 month; wore OK lenses or other myopia intervention methods (such as red light-related treatment methods) within 3 months. 8. History of systemic medication (drugs that affect growth and development, such as growth hormone); 9. Has participated in any clinical research trials for myopia control within the past month; 10. The researchers believe that there are other circumstances that make someone ineligible to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Change in Axial length;

Secondary

MeasureTime frame
Sphere power, cylinder power, axis;Changes in contrast sensitivity;change in axial length;Choroidal Thickness;

Countries

China

Contacts

Public ContactWeiwei Lu

Eye Hospital, Wenzhou Medical University

lww@eye.ac.cn+86 571 86726050

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Aug 25, 2026