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Randomized, controlled, multisite, subject- and observer-masked, contralateral clinical trial of 6-month duration to compare two SightGlass Vision Diffusion Optics Technology (DOT) spectacle lens manufacturing processes in reducing the progression of juvenile myopia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DOT Spectacle Lenses using Manufacturing Method A | Experimental | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A |
|
| DOT Spectacle Lenses using Manufacturing Method B | Experimental | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SightGlass Vision DOT Spectacle Lenses | Device | Subjects randomized to test vs control, left eyes and right eyes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in Axial Length Progression From Baseline | Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Joseph Rappon, OD, MS, FAAO | SightGlass Vision, Inc. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sabal Eye Care | Longwood | Florida | 32779 | United States | ||
| Kannarr Eye Care |
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| ID | Title | Description |
|---|---|---|
| FG000 | DOT Spectacle Lenses Test | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes |
| FG001 | DOT Spectacle Lenses Control | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
This was a contralateral eye study of 50 participants in which both eyes were enrolled. In the analysis set, each group has 43 eyes with a total of 43 participants.
| ID | Title | Description |
|---|---|---|
| BG000 | DOT Spectacle Lenses Test | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes |
| BG001 | DOT Spectacle Lenses Control |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Units |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Axial Length Progression From Baseline | Change in axial length progression over time between DOT spectacle lenses manufactured by method A versus method B Axial length progression is defined as an axial length elongation that is attributable to myopia. | Posted | Mean | Standard Deviation | mm | 6 months | Eyes | Eyes |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | DOT Spectacle Lenses Using Test | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method A SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joe Rappon, OD, MS, FAAC | SightGlass Vision, Inc. | 678-642-9117 | joe@sightglassvision.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 5, 2020 | Dec 3, 2021 | Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Aug 5, 2020 | Oct 29, 2021 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009216 | Myopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
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|
| Pittsburg |
| Kansas |
| 66762 |
| United States |
| Advanced Eyecare PC | Raytown | Missouri | 64133 | United States |
| SUNY School of Optometry | New York | New York | 10036 | United States |
| William J Bogus, OD, FAAO | Salt Lake City | Utah | 84106 | United States |
Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes |
| BG002 | Total | Total of all reporting groups |
| Eyes |
|
| Eyes |
| Eyes |
|
| Age, Continuous | Mean | Standard Deviation | years | Participants |
|
| Sex: Female, Male | Count of Units | Eyes | Eyes |
|
| Ethnicity (NIH/OMB) | Count of Units | Eyes | Eyes |
|
| Race (NIH/OMB) | Count of Units | Eyes | Eyes |
|
| Region of Enrollment | Number | Eyes | Eyes |
|
|
|
| 0 |
| 43 |
| 0 |
| 43 |
| 0 |
| 43 |
| EG001 | DOT Spectacle Lenses Using Control | Single vision, impact-resistant spectacles using SightGlass Vision DOT spectacle lenses, manufacturing method B SightGlass Vision DOT Spectacle Lenses: Subjects randomized to test vs control, left eyes and right eyes | 0 | 43 | 0 | 43 | 0 | 43 |
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