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A Randomized, Parallel-Controlled, Open-Label, Single-Center Clinical Trial Evaluating the Efficacy of Hongchen Student Myopia Prevention Multi-Point Micro-Transparent Defocus Lenses in Myopia Prevention

A Randomized, Parallel-Controlled, Open-Label, Single-Center Clinical Trial Evaluating the Efficacy of Hongchen Student Myopia Prevention Multi-Point Micro-Transparent Defocus Lenses in Myopia Prevention

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107383
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-08-12
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

myopia

Interventions

experimental group:Multi-point micro-transparent defocus lens

Sponsors

The Second Affiliated Hospital of Anhui Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 15 Years

Inclusion criteria

Inclusion criteria: 1.Age between 8 and 15 years old, no gender restrictions; 2.Bilateral myopia ranging from -0.00D (including -0.00D) to -6.00D (including -6.00D), astigmatism ranging from -0.00D (including -0.00D) to -2.00D (including -2.00D), and refractive anisometropia less than 2.00D; 3.Best-corrected visual acuity with spectacle correction in both eyes >= 1.0; 4.Able to understand the purpose of the trial, voluntarily participate, and sign an informed consent form; 5.Able to accept random assignment to a trial group, agree to follow-up visits according to the specified schedule, and comply with the prescribed lens wearing duration requirements.

Exclusion criteria

Exclusion criteria: 1.Patients with the following contraindications: (1) Those with various eye conditions, such as acute or chronic eye inflammation, glaucoma, corneal sensory abnormalities, corneal epithelial defects, reduced corneal endothelial cell count, dry eye syndrome, etc., as determined by an ophthalmologist to be unsuitable for contact lens wear; (2) Those with systemic diseases that may affect the eyes, such as hyperthyroidism, diabetes, mental disorders, etc., as determined by an ophthalmologist to be unsuitable for contact lens wear; 2.Patients currently using medications that the investigator determines may affect contact lens wear, tear film, pupil size, accommodation, or refractive status; 3.Patients with a history of ocular trauma or corneal surgery that may affect contact lens wear; 4. Patients with manifest strabismus; 5. Patients with abnormal intraocular pressure or fundus examination findings; 6.Patients with active ocular diseases or other slit-lamp examination abnormalities that the investigator determines make them unsuitable for participation in the study; 7.Participants who have participated in other clinical trials within the past 3 months prior to screening; 8.Other conditions deemed by the investigator to be unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
360-day equivalent sphericity change;

Secondary

MeasureTime frame
Changes in axial length at 360-day intervals;

Countries

China

Contacts

Public ContactTao Liming

The Second Affiliated Hospital of Anhui Medical University

taoliming_gcp@163.com+86 136 0551 7183

Outcome results

None listed

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