Effectiveness of DIMS Spectacle as a Function of the Age
NCT ID: NCT06556849
Last Updated: 2024-08-20
Study Results
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Basic Information
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COMPLETED
80 participants
OBSERVATIONAL
2020-12-01
2024-06-30
Brief Summary
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Methods: This was a non-randomized experimenter-masked retrospective controlled observational study of European individuals aged 6 -16 years with progressive myopia but no ocular pathology. The charts of the participants allocated to receive DIMS spectacles (Hoya® MiyoSmart®) or single vision spectacle lenses (control group) were retrospectively reviewed. The key outcome variables, cycloplegic spherical equivalent (SE) and axial length (AL), were measured at baseline and at 36 month follow up. The results were stratified by age into four groups: patients that wore DIMS spectacles oldest or youngest than 10 years (respectively, group A, 20 patients mean age 13.6±2.2 and group C, 20 patients mean age 9.0±1.2) and age matched control groups (group B, 18 patients mean age 13.2±2.5 and group D, mean age 8.5±0.9).
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
RETROSPECTIVE
Study Groups
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Group A: patients oldest than 10 years that wear DIMS lens
myopic patients oldest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles
Defocus Incorporated Multiple Segments (DIMS)
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Group B: patients oldest than 10 years that wear (control group)
myopic patients oldest than 10 years of age that wore single vision spectacle lenses (control group)
Defocus Incorporated Multiple Segments (DIMS)
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Group C: patients youngest than 10 years that wear DIMS lens
myopic patients youngest than 10 years of age that wore Defocus Incorporated Multiple Segments (DIMS) spectacles
Defocus Incorporated Multiple Segments (DIMS)
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Group D: patients youngest than 10 years (control group)
myopic patients youngest than 10 years of age that wore single vision spectacle lenses (control group)
Defocus Incorporated Multiple Segments (DIMS)
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Interventions
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Defocus Incorporated Multiple Segments (DIMS)
To evaluate the effectiveness of Defocus Incorporated Multiple Segments (DIMS) in slowing myopia progression as a function of age in pediatric patients.
Eligibility Criteria
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Inclusion Criteria
* progressive myopia with cycloplegic spherical equivalent (SE) from -0.50 to -4.00 diopters (D)
* astigmatism less than 2.50D, anisometropia under 1.25D
Exclusion Criteria
* systemic diseases
* eye diseases (such as glaucoma, juvenile cataracts, retinal abnormalities, any form of strabismus)
6 Years
16 Years
ALL
No
Sponsors
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Luca Buzzonetti
OTHER
Responsible Party
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Luca Buzzonetti
Head of Ophthalmology Unit
Principal Investigators
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Luca Buzzonetti
Role: PRINCIPAL_INVESTIGATOR
Bambino Gesù IRCCS Children's Hospital
Locations
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Luca Buzzonetti
Rome, , Italy
Countries
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Other Identifiers
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Myopia1
Identifier Type: -
Identifier Source: org_study_id
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