RecruitingNot ApplicableNCT07323251

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

Sponsor

Beijing Tongren Hospital

Enrollment

120 participants

Start Date

Aug 2, 2024

Study Type

INTERVENTIONAL

Conditions

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

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.

Eligibility

Min Age: 6 YearsMax Age: 14 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a medical device called Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses for people with children with myopia, efficacy, and other related conditions. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DEVICEDiverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses

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