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Inhibition of Myopia Progression With Optical Devices

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 6
Maximum Age: 15
Healthy Volunteers: f
View:

• • 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

Locations
Other Locations
Hungary
Semmelweis University Ophthalmology Department
RECRUITING
Budapest
Contact Information
Primary
Zoltan Zs Nagy, Professor
szem.titkarsag@gmail.com
+3614591500
Backup
Amarilla Barcsay-Veres
veres.amarilla@semmelweis.hu
+3614591500
Time Frame
Start Date: 2026-06-02
Estimated Completion Date: 2027-05-31
Participants
Target number of participants: 50
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Semmelweis University

This content was sourced from clinicaltrials.gov