NCT07698977 Inhibition of Myopia Progression With Optical Devices
| NCT ID | NCT07698977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Semmelweis University |
| Condition | Myopia Progression |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2026-06-02 |
| Primary Completion | 2027-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2026-06-02 with a primary completion date of 2027-05-31.
⚠ 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
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.
Eligibility Criteria
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
Contact & Investigator
Zoltan Zs Nagy, Professor
PRINCIPAL INVESTIGATOR
Semmelweis University Ophthalmology Department
Frequently Asked Questions
Who can join the NCT07698977 clinical trial?
This trial is open to participants of all sexes, aged 6 Years or older, up to 15 Years, studying Myopia Progression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07698977 currently recruiting?
Yes, NCT07698977 is actively recruiting participants. Contact the research team at szem.titkarsag@gmail.com for enrollment information.
Where is the NCT07698977 trial being conducted?
This trial is being conducted at Budapest, Hungary.
Who is sponsoring the NCT07698977 clinical trial?
NCT07698977 is sponsored by Semmelweis University. The principal investigator is Zoltan Zs Nagy, Professor at Semmelweis University Ophthalmology Department. The trial plans to enroll 50 participants.