Inhibition of Myopia Progression With Optical Devices

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.

Study Overview

• Status: Recruiting
• Conditions: Myopia; Myopia Progression; Myopia, Child Myopia Progression
• Intervention / Treatment: Device: Wearing myopia-control D.I.M.S. glasses while awake; Device: DIMS (Defocus Incorporated Multiple Segments) lenses

Detailed Description

As an observational study we aim to examine the effects of D.I.M.S. lens's daily wear on myopia progression in relation to the environmental factors.

Our pediatric and adolescent myopic population is selected as follows:

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 during waking hours
• Willing to Participate in follow-up examinations up to 24 weeks

Exclusion criteria:

• pathological myopia (e.g., myopia onset before age 6, Stickler syndrome)
• preterm infants born before 32 weeks of gestation
• previous eye-opening surgery (e.g., lens extraction)
• 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

In the self-controlled observational study the myopic participants are wearing during day time DIMS glasses. DIMS stands for "defocus incorporated multiple segments," a specialized optical technology used in spectacle lenses to slow nearsightedness progression in children. DIMS glasses not only correct the refractive errror but also provide a circular defocus zone to avoid periferial retinal defocus.

Patients will keep a diary of their subjective symptoms and environmental factors, e.g., time spent outdoors and screen time, subjective symptoms.

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 These measurements and tests are part of the regular ophthalmological follow-up examinations.

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? Statistical analysis plan includes non-parametric t-test, one way and two way ANOVA tests.

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Zoltan Zs Nagy, Professor; Phone Number: +3614591500; Email: szem.titkarsag@gmail.com
• Study Contact Backup: Name: Amarilla Barcsay-Veres; Phone Number: +3614591500; Email: veres.amarilla@semmelweis.hu

Study Locations

• Hungary
  • Budapest, Hungary, 1085
    • Recruiting
    • Semmelweis University Ophthalmology Department
    • Contact: Zoltan Zs Nagy, Professor; Phone Number: +3614591500; Email: szem.titkarsag@semmelweis.hu
    • Contact: Amarilla Barcsay-Veres, PhD; Phone Number: +3614591500; Email: veres.amarilla@semmelweis.hu
    • Sub-Investigator: Otto A Maneschg, PhD
    • Sub-Investigator: Amarilla Barcsay-Veres, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Participants (between 6 and 15 years of age) are wearing myopia progression treatment , namely D.I.M.S. lenses while they are awake. The wear these glasses to correct refractive error and to slow down myopia progression.

At enrollment the refractive error measured under cycloplegia, expressed as spherical equivalent must be: between -0.50 Dsph and -10.0 Dsph.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Best corrected visual acuity test	Zero is equivalent to no vision and 1.0 indicates the best visual acuity in decimal scale. Distance and near visual acuity is measured under standard conditions	up to 24 week
Bulbar axial length measurement	It is defined as the distance from the anterior surface of the cornea to the retinal pigment epithelium, measured in millimeters using optical device. An increase in axial length is characteristic of the elongation of the eye.	up to 24 week

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Stereopsis	stereopsis test (depth perception test) measures how well the eyes create three-dimensional vision. The precision of depth perception is measured in seconds of arc (arcsec) using a test plate. If stereoscopic vision is present, the smaller the angle, the more refined the stereopsis.	up to 24 week

Collaborators and Investigators

• Sponsor: Semmelweis University
• Investigators: Principal Investigator: Zoltan Zs Nagy, Professor, Semmelweis University Ophthalmology Department

Study record dates

Study Major Dates

• Study Start (Actual): June 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027

Study Registration Dates

• First Submitted: June 27, 2026
• First Submitted That Met QC Criteria: July 7, 2026
• First Posted (Actual): July 13, 2026

Study Record Updates

• Last Update Posted (Actual): July 13, 2026
• Last Update Submitted That Met QC Criteria: July 7, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: myopia progression; myopia; optical device; DIMS lenses; bulbar axial length
• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Myopia; Equipment and Supplies; Optical Devices; Lenses
• Other Study ID Numbers: SE-RKEB 222/2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes