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An Exploratory Study on the Effects of a Novel, Specially-Designed Myopia Control Spectacle Lens on Axial Length Change and Visual Acuity Correction in Children and Adolescents.

An Exploratory Study on the Effects of a Novel, Specially-Designed Myopia Control Spectacle Lens on Axial Length Change and Visual Acuity Correction in Children and Adolescents

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500114538
Enrollment
Unknown
Registered
2025-12-15
Start date
2025-12-15
Completion date
Unknown
Last updated
2026-01-05

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

Conditions

myopia

Interventions

Control Group:Novel, Specially-Designed Myopia Control Spectacle Lens

Sponsors

Shanghai Eye Disease Prevention and Treatment Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1. Aged 6 to 12 years, regardless of gender. 2. Ability to provide informed consent, signed by a parent or legal guardian who understands and accompanies the participant. 3. Spherical equivalent refraction under cycloplegia = -0.50 diopters (D) and > -3.00 D in both eyes; anisometropia and astigmatism = 1.50 D; best-corrected visual acuity (BCVA) of 0.8 or better in both eyes. 4. Willingness to wear exclusively the spectacles provided by the investigator for more than 10 hours per day throughout the study period, with no additional myopia control interventions.

Exclusion criteria

Exclusion criteria: 1. Known allergy or intolerance to cycloplegic agents. 2. Use of any myopia control intervention within the past 3 months, including but not limited to: atropine, orthokeratology (OK) lenses, defocus spectacle lenses/multifocal soft contact lenses, or red light therapy. 3. Diagnosis of any ocular condition other than myopia in either eye, including but not limited to: manifest strabismus, corneal disease, conjunctival or eyelid injury, or other disorders (e.g., keratoconus, herpes simplex keratitis); history of ocular surgery (including strabismus surgery); any ocular or systemic disease that may be associated with myopia or its progression, such as Marfan syndrome, retinopathy of prematurity, diabetes mellitus, etc. 4. Any other condition which, in the opinion of the investigator, would make the participant unsuitable for inclusion in the study.

Design outcomes

Primary

MeasureTime frame
Change in Axial Length;—

Secondary

MeasureTime frame
Change in Visual Acuity;Visual Quality, Daily Wear Time, Adverse Event Occurrence;Change in Choroidal Thickness, Peripheral Refraction, Change in Accommodative Response;—

Countries

China

Contacts

Public ContactHe Xiangui

Shanghai Eye Disease Prevention and Treatment Center

xianhezi@163.com+86 21 62539696

Outcome results

None listed

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