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

NCT07323251 | Recruiting

• 1 other identifier: TREC2024-KY161
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Change in Spherical Equivalent Refraction (SER)

  From enrollment to the end of treatment at 12 months

Study Arms (2)

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

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

This clinical trial employs a randomized, parallel-group, superiority design to evaluate two novel optical designs of Diverse Segments Defocus Optimization (D.S.D.O.) myopia management spectacle lenses. A total of 60 myopic Chinese children, aged 6 to 14 years, will be recruited and randomly assigned in a 1:1 ratio to one of two intervention groups. Both groups will receive myopia control spectacles: the Control Group will use D.S.D.O. Lens Design 1, and the Intervention Group will use D.S.D.O. Lens Design 2. Participants are required to wear the assigned spectacles daily for the entire 12-month study duration, except during sleep or other unavoidable circumstances. The spectacles are intended to provide full refractive correction for distance vision while simultaneously incorporating defocus modifications designed to slow myopia progression by manipulating peripheral retinal defocus patterns. The study includes a baseline visit, a dispensing visit, and follow-up assessments at 3, 6, 9

Multi-lens zoning myopia defocus Lens 1 (D.S.D.O); Multi-lens zoning myopia defocus Lens 2(D.S.D.O)

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Beijing Tongren Hospital: lead

Study Sites (1)

Beijing Tongren Hospital

Beijing, China

RECRUITING

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Generation of random sequences, determination of random number grouping, and inclusion of subjects by different staff members.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 13, 2025
• First Posted: January 7, 2026
• Study Start: August 2, 2024
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

CN (1)