Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression

Capital Medical University

Status: Enrolling

Conditions: Visual Quality; Multizone Lens Design for Myopic Defocus; Treatment; Children With Myopia; Efficacy

Treatments: Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses

Study type: Interventional

Funder types: Other

Identifiers

NCT07323251

TREC2024-KY161

Details and patient eligibility

About

Clinical Trial

The goal of this clinical trial is to evaluate the effectiveness of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing myopia progression in children. It will also assess the safety of these lenses. The main questions it aims to answer are:

Do D.S.D.O. lenses reduce the progression of myopia as measured by changes in cycloplegic refraction and axial length? What adverse events do participants experience when wearing D.S.D.O. lenses? Researchers will compare two optical designs of D.S.D.O. lenses (Intervention Group1: Design 1; Intervention Group2: Design 2) to determine their relative efficacy in controlling myopia progression.

Participants will:

Wear assigned D.S.D.O. lenses daily for 12 months (except during sleep or unavoidable situations).

Attend clinic visits at baseline, 3, 6, 9, and 12 months for comprehensive eye examinations.

Maintain a diary recording daily wear time, visual symptoms, and any adverse events.

Enrollment: 120 estimated patients

Sex: All

Ages: 6 to 14 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age 6-14 years
• Myopic spherical equivalent refraction between -0.75D and -4.00D (inclusive of -0.75D and -4.00D, based on cycloplegic refraction)
• Astigmatism ≤1.50D
• Anisometropia ≤1.50D
• Best-corrected visual acuity (BCVA) reaching 5.0 (0.00 LogMAR) or better in both eyes; monocular BCVA reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles
• Absence of organic ocular diseases
• No history of myopia control treatment within the past three months, including orthokeratology, progressive multifocal lenses, peripheral defocus spectacle lenses, bifocal spectacle lenses, defocus-designed soft hydrophilic contact lenses, other myopia control medications, or light-therapy devices
• Voluntary participation in this clinical study and provision of signed informed consent

Exclusion criteria

• History of ocular trauma or surgery
• Systemic diseases affecting visual function
• Inability to cooperate with examinations
• Poor compliance
• Inability to adhere to wearing requirements and follow-up visits during the trial period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 2 patient groups

Multi-lens zoning myopia defocus Lens 1 (D.S.D.O)

Experimental group

Treatment:

Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses

Multi-lens zoning myopia defocus Lens 2(D.S.D.O)

Experimental group

Treatment:

Device: Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses