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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-14
SponsorBeijing Tongren Hospital

About this trial

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

Qualifiers

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

Disqualifiers

History of ocular trauma or surgery

Systemic diseases affecting visual function

Inability to cooperate with examinations

Poor compliance

Trial design

Treatments tested in this trial

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

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators