Inhibition of Myopia Progression With Optical Devices

NCT07698977 | Recruiting FDA Device

• 1 other identifier: SE-RKEB 222/2026
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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:

• 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

Keywords

myopia; myopia progression; optical device; DIMS lenses; bulbar axial length

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Stereopsis

  up to 24 week

Study Arms (1)

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; Device: DIMS (Defocus Incorporated Multiple Segments) lenses

Interventions

Wearing myopia-control D.I.M.S. glasses while awake DEVICE

DIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake

Myopic cohort

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.

Myopic cohort

Eligibility Criteria

• Age: 6 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Semmelweis University: lead

Study Sites (1)

Semmelweis University Ophthalmology Department

Budapest, 1085, Hungary

RECRUITING

MeSH Terms

Conditions

Myopia

Interventions

Lenses

Condition Hierarchy (Ancestors)

Refractive Errors; Eye Diseases

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies

Study Officials

• Zoltan Zs Nagy, Professor

  Semmelweis University Ophthalmology Department

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zoltan Zs Nagy, Professor

CONTACT

+3614591500; szem.titkarsag@gmail.com

Amarilla Barcsay-Veres

CONTACT

+3614591500; veres.amarilla@semmelweis.hu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigatorr

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 13, 2026
• Study Start: June 2, 2026
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: July 13, 2026

Record last verified: 2026-07

Locations

HU (1)