Inhibition of Myopia Progression With Optical Devices

Sponsor
Semmelweis University
Study ID
NCT07698977
Status
Recruiting
Apply to this trial

Conditions

  • Myopia
  • Myopia Progression
  • Myopia, Child Myopia Progression

Eligibility Criteria

Sex
ALL
Age
6 Years - 15 Years
Healthy Volunteers
Not accepted

Interventions

  • Wearing myopia-control D.I.M.S. glasses while awake — DEVICE
    DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
  • DIMS (Defocus Incorporated Multiple Segments) lenses — DEVICE
    D.I.M.S. lenses are worn like normal glasses to correct myopia and, beyond that, their special design is intended to slow myopia progression via defocus lenslets. There is targeted myopic defocus produced by the mid-peripheral lenslets with positive power to inhibit eye length growth.

Study Details

This observational study aims to determine whether optical devices designed to slow myopia progression and/or environmental factors can prevent myopia progression in the pediatric and adolescent myopic population. The study aims to answer the following questions: 1. How does myopia progression change with age while wearing myopia progression control glasses? 2. How does myopia progression change while wearing myopia progression-control glasses when environmental factors, such as time spent outdoors and place of residence, are taken into account? 3. How does myopia progression change at different ages while wearing myopia progression control glasses given a family history of myopia? This will be a self-controlled observational study. Participants who are myopic after cycloplegic refraction will be prescribed DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time. Patients will visit the clinic once every six months for checkups and the following tests: * Best corrected visual acuity test * Stereopsis * Automatic refractometry * Bulbar axial length measurement In a follow-up study, researchers will compare myopia progression with environmental and baseline factors to learn about the long-term effects of DIMS lenses on myopia progression.

Key Dates

First listed
Jul 13, 2026
Start date
Jun 2, 2026
Status verified
Jul 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)

Arms

  • Arm: Myopic cohort
    Inclusion Criteria: * Participants must be between 6 and 15 years of age at the start of myopia progression treatment * Caucasian ethnicity * Refractive error measured under cycloplegia, expressed as spherical equivalent: between -0.50 Dsph and -10.0 Dsph * Wearing myopia-control glasses while awake * Participation in follow-up examinations every 6 months Exclusion criteria: * Pathological myopia (e.g., myopia onset before age 6, Stickler syndrome) * Premature birth before the 32nd week of gestation * Previous eye-opening surgery (e.g., lens removal) * Traumatic eye injury * Known connective tissue disorder (e.g., Marfan syndrome) * Irregular or improper use of progressive-lens glasses * Failure to attend the follow-up examinations scheduled every 6 months

Primary Outcome Measure

Best corrected visual acuity test [ Time Frame: up to 24 week ]

Central Contacts

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