Inhibition of Myopia Progression With Optical Devices
NCT07698977 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 50
Last updated 2026-07-13
Summary
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.
Conditions
- Myopia Progression
- Myopia
- Myopia, Child Myopia Progression
Interventions
- DEVICE
-
Wearing myopia-control D.I.M.S. glasses while awake
DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
- DEVICE
-
DIMS (Defocus Incorporated Multiple Segments) lenses
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.
Sponsors & Collaborators
-
Semmelweis University
lead OTHER
Principal Investigators
-
Zoltan Zs Nagy, Professor · Semmelweis University Ophthalmology Department
Eligibility
- Min Age
- 6 Years
- Max Age
- 15 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-06-02
- Primary Completion
- 2027-05-31
- Completion
- 2027-05-31
- FDA Device
- Yes
Countries
- Hungary
Study Locations
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