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Prospective, randomized, subject-masked 3-arm clinical study to assess the pediatric acceptability across three iterations of a novel spectacle lens design.
This feasibility study was conducted to assess the performance of three experimental spectacle lens designs (spectacle lenses) in children between 6 and 9 years of age with myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lens Design 1 | Experimental | Spectacle lenses design 1, fitted into spectacle frames |
|
| Lens Design 2 | Experimental | Spectacle lenses design 2, fitted into spectacle frames |
|
| Lens Design 3 | Experimental | Spectacle lenses design 3, fitted into spectacle frames |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spectacle lenses | Device | Spectacle lenses with clear central apertures |
|
| Measure | Description | Time Frame |
|---|---|---|
| Distance Visual Acuity | Measurement of best corrected distance visual acuity | 2 weeks |
| Contrast Sensitivity | Measurement of contrast sensitivity | 2 weeks |
| Subjective Responses | Assessment of subject responses related to wear time of spectacles | 2 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joe Rappon, OD, MS | SightGlass Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Ocular Research & Education | Waterloo | Ontario | N2L 3G1 | Canada |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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