Inhibition of Myopia Progression With Optical Devices
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-15
SponsorSemmelweis University
About this trial
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
This trial does not accept healthy volunteersQualifiers
• 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
Disqualifiers
• 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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Wearing myopia-control D.I.M.S. glasses while awake
DeviceDIMS (Defocus Incorporated Multiple Segments) lenses wearing while awake
DIMS (Defocus Incorporated Multiple Segments) lenses
DeviceD.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.
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Myopic cohort2 interventions
Trial outcomes
Primary outcomes
1
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
Time frame
up to 24 week2
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.
Time frame
up to 24 weekSecondary outcomes
1
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.
Time frame
up to 24 weekSponsors and contacts
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Source ClinicalTrials.gov