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The aim of this clinical study is to compare the efficacy of DIMS technology spectacle lenses with conventional single vision spectacle lenses at slowing the progression of myopia in the category of children and young adults during three years.
The study is non randomized, unmasked, observational and prospective. Participants aged 6-26 with progressing myopia (but no ocular pathology), all Caucasian, are divided in two groups according to single vision spectacle lenses (SV) and DIMS technology lenses (DIMS). The participants are followed during three years (axial length, refraction changes).
Defocus incorporated multiple segments (DIMS) spectacle lenses were designed to slow myopia progression in children, based on the principle of peripheral myopic defocus. DIMS spectacles reduce the progression of myopia and reduce axial elongation by 50-60% compared to single vision (SV) lenses according to previous scientific studies conducted mostly on the Asian population under the age of 15.
The majority of myopia appears and progresses during childhood. The myopia stabilizes by the age of 18 years, a number of individuals may still present myopic changes.
The goals of our study:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single Vision Spectacle Lens | Participants who chose to correct myopia with single vision spectacle lenses. |
| |
| Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens | Participants who chose to correct myopia with DIMS spectacle lenses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single Vision Spectacle Lens | Other | 36 months of therapy |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Axial length of eye | biometry (Lenstar 900) | in 36 moths therapy |
| Measure | Description | Time Frame |
|---|---|---|
| Objective refraction | autorefractometer (Huwitz) | in 36 month therapy |
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Inclusion Criteria:
Exclusion Criteria:
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To evaluate the efficacy of Defocus Incorporated Multiple Segment (DIMS) lenses in slowing myopia progression in a young European population of progressing myopes. A prospective, non-randomized, observational 3 - year study will be conducted in 80 progressing myopes aged 6-26 years, with myopia between -0,25D and -8,5D and astigmatism -0,25 and -2,25DC. Participants self-selected wearing DIMS (n=55) or single vision (SV) lenses (n=25). Spherical Equivalent Refraction (SER, cycloplegic autorefraction) and axial length (AL) were measured at baseline. AL will be measured at 3M, 6M and every 6M and SER will be measured every 12M.
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| Name | Affiliation | Role |
|---|---|---|
| Marketa Zakova, Ph.D. | Czech Technical University in Prague | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Czech Technical University | Prague | Czech Republic | Czechia |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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| Defocus Incorporated Multiple Segments (DIMS) Spectacle Lens |
| Other |
36 months of therapy |
|