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Clinical study on the effectiveness and safety of horizontal complementary designed lenses in slowing the progression of myopia in adolescents

Clinical study on the effectiveness and safety of horizontal complementary designed lenses in slowing the progression of myopia in adolescents

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500109669
Enrollment
Unknown
Registered
2025-09-23
Start date
2024-04-14
Completion date
Unknown
Last updated
2025-09-29

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

Conditions

Myopia

Interventions

Control group: Essilor Stellest control lenses:Control group: The lenses utilize the Highly-Aspheric Lenslet Technology (HALT) technology, with 11 concentric rings of 1,021 micro-lenses distributed ac
Trial group: Parallel complementary lenses:Trial group: A parallel complementary design was used for the spectacle lenses, where the clear zone and blurred zone were arranged in a horizontal stripe pa

Sponsors

The Affiliated Eye Hospital of Wenzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 12 Years

Inclusion criteria

Inclusion criteria: 1.Adolescents and children, aged 6 to 12 years; 2.Spherical refractive error of both eyes: -0.75 to -4.50 D (including -0.75 D and -4.50 D); 3. Astigmatism <= -1.50 D; 4.Willing to wear spectacle lenses and able to accept random assignment; 5. Compliant with follow-up examination schedules and cooperative during examinations.

Exclusion criteria

Exclusion criteria: 1. Intraocular Pressure (IOP) > 21 mmHg; 2. Patients with binocular vision abnormalities, manifest strabismus, or intermittent exotropia with a large angle (> 20 prism diopters [?]); 3. Best-corrected Visual Acuity (BCVA) < 4.9 in either eye; 4. Ocular diseases (other than refractive errors) or systemic diseases that affect visual development; 5. A history of ocular or systemic surgery that affects ocular development; 6. Previous wear of defocus lenses, or use of low-concentration atropine eye drops within 6 months; previous wear of orthokeratology (OK) lenses or use of other myopia intervention methods (e.g., red light-related treatment methods); 7. A history of systemic medication use (drugs affecting growth and development, e.g., growth hormone); 8. Current participation in any clinical research trial on myopia control; 9. Other conditions deemed unsuitable for trial participation by the researcher.

Design outcomes

Primary

MeasureTime frame
Axial length;Refractive errors;

Secondary

MeasureTime frame
Contrast sensitivity;Choroidal thickness and blood flow;Binocular visual function;

Countries

China

Contacts

Public ContactYu Lihua

The Affiliated Eye Hospital of Wenzhou Medical University

783567149@qq.com+86 139 6889 1235

Outcome results

None listed

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