Actively Recruiting

Phase Not Applicable
Age: 6Years - 14Years
All Genders
Healthy Volunteers
NCT07323251

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

Led by Beijing Tongren Hospital · Updated on 2026-01-07

120

Participants Needed

1

Research Sites

112 weeks

Total Duration

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AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Years - 14Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

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 of 5.0 (0.00 LogMAR) or better in both eyes
  • Monocular best-corrected visual acuity of 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
Not Eligible

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 follow wearing requirements and attend follow-up visits during the trial

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Beijing Tongren Hospital

Beijing, China

Actively Recruiting

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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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