NCT07323251 Clinical Study on the Effectiveness of Diverse Segments Defocus Optimization in Spectacle Lenses for Slowing Myopia Progression
| NCT ID | NCT07323251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Beijing Tongren Hospital |
| Condition | Children With Myopia |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-08-02 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-08-02 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Frequently Asked Questions
Who can join the NCT07323251 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 14 Years, studying Children With Myopia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07323251 currently recruiting?
Yes, NCT07323251 is actively recruiting participants. Visit ClinicalTrials.gov or contact Beijing Tongren Hospital to inquire about joining.
Where is the NCT07323251 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07323251 clinical trial?
NCT07323251 is sponsored by Beijing Tongren Hospital. The trial plans to enroll 120 participants.