Actively Recruiting
Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization Spectacle Lenses for Slowing Myopia Progression in Children
Led by Beijing Tongren Hospital · Updated on 2026-01-07
120
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of two types of Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses in slowing the progression of myopia in children aged 6 to 14 years. The study aims to determine whether these lenses can reduce the worsening of myopia by measuring changes in cycloplegic refraction and axial length over a 12-month period. The research compares two optical designs of D.S.D.O. lenses to see which design better controls myopia progression. Participants will be randomly assigned to wear one of the two D.S.D.O. spectacle lens designs daily for 12 months, except during sleep or unavoidable situations. These lenses provide full refractive correction for distance vision while modifying peripheral retinal defocus to potentially slow myopia. The study includes visits at baseline and follow-up assessments at 3, 6, 9, and 12 months to monitor progress and safety. During the study, participants will attend clinic visits for comprehensive eye exams and maintain a daily diary to record wear time, visual symptoms, and any adverse events. Researchers will closely monitor changes in spherical equivalent refraction as the primary outcome to assess lens effectiveness. Safety and adherence to lens wear and follow-up visits will also be tracked throughout the trial period, which lasts one year.
CONDITIONS
Brief Title
Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 6 to 14 years
- Myopic spherical equivalent refraction between -0.75D and -4.00D based on cycloplegic refraction
- Astigmatism of 1.50D or less
- Anisometropia of 1.50D or less
- Best-corrected visual acuity reaching 5.0 (0.00 LogMAR) or better in both eyes
- Monocular best-corrected visual acuity reaching 5.0 (0.00 LogMAR) or better after wearing myopic defocus spectacles
- No organic ocular diseases
- No history of myopia control treatment within the past three months
- Voluntary participation with signed informed consent
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 months
Participants wear assigned Diverse Segments Defocus Optimization (D.S.D.O.) spectacle lenses daily to slow myopia progression.
Baseline visit, dispensing visit, and follow-up visits at 3, 6, 9, and 12 months
Trial Site Locations
Total: 1 location
1
Beijing Tongren Hospital
Beijing, China
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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