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Randomized controlled clinical study on the effectiveness of four-zone multiple segments bifocal defocus lens in myopia control in children

Randomized controlled clinical study on the effectiveness of four-zone multiple segments bifocal defocus lens in myopia control in children

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083900
Enrollment
Unknown
Registered
2024-05-07
Start date
2024-05-07
Completion date
Unknown
Last updated
2024-05-13

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

Conditions

myopia

Interventions

Experimental group:Wear four-zone multiple segments bifocal defocus lens
Control group:Wear single vision lens

Sponsors

West China Hospital of Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
8 Years to 12 Years

Inclusion criteria

Inclusion criteria: (1) Age: 8 ~ 12 years old (including 8 and 12 years old); (2) Myopia of both eyes was between -0.75D and -6.00D, and the difference was less than 1.50D; Astigmatism =1.50D; (3) The best corrected visual acuity in both eyes =1.0 (fractional recording); (4) The subjects can come to the hospital regularly for follow-up;

Exclusion criteria

Exclusion criteria: (1) Ocular diseases such as keratitis, pink eye, acute inflammation, glaucoma, strabismus, and nystagmus; (2) Have worn other myopia control methods (such as: orthokeratology lens, multi-focus soft contact lens, red-light therapy, multiple segments defocus glasses, etc.); (3) Participants who have participated in clinical studies to myopia progression; (4) Suffering from mental illness; (5) Suffering from systemic diseases, such as cardiopulmonary insufficiency, diabetes, hypertension, etc (6) Poor compliance, the researchers think it is not appropriate to continue to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Subjective and objective refraction;Visual acuity;Axial length;

Secondary

MeasureTime frame
Contrast sensitivity;Optical coherence tomography;Visual quality questionnaire;Binocular vision function test;Prism test;

Countries

China

Contacts

Public ContactLiu Longqian

West China Hospital of Sichuan University

b.q15651@hotmail.com+86 189 8060 1759

Outcome results

None listed

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