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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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The purpose of this study is to evaluate the visual outcomes of the Symfony lens and the Vivity lens under mesopic lighting conditions in adult patients undergoing routine cataract surgery. Participants will be asked to read a visual acuity chart at different distances in dim light.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symfony IOL | Active Comparator | The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
|
| Vivity IOL | Active Comparator | The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symfony IOL | Device | The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | logMAR visual acuity | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | 3 months after surgery | |
| Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | Visual acuity measured at 4 m |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Sight | Sarasota | Florida | 34239 | United States | ||
| Carolina Eyecare Physicians, LLC |
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| ID | Title | Description |
|---|---|---|
| FG000 | Symfony Optiblue IOL | The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
| FG001 | Clareon Vivity IOL | The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Symfony Optiblue IOL | The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up tp 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Binocular Distance Corrected Intermediate Visual Acuity at 66 cm Under Mesopic Conditions. | logMAR visual acuity | Posted | Mean | Standard Deviation | logMAR | 3 months after surgery |
|
3 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 | Symfony Optiblue IOL | The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Symfony IOL: The Symfony IOL is a lens designed to provide high quality vision up to 26 inches reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Carolina Eyecare Physicians, LLC | 8438813937 | hsandoval@cepmd.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 22, 2023 | Jan 23, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Vivity IOL | Device | The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
|
| 3 months after surgery |
| Mt. Pleasant |
| South Carolina |
| 29464 |
| United States |
| BG001 | Clareon Vivity IOL | The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
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| Secondary | Binocular Distance Corrected Intermediate Visual Acuity at 40 cm Under Mesopic Conditions. | Posted | Mean | Standard Deviation | logMAR | 3 months after surgery |
|
|
|
| Secondary | Binocular Low Contrast Distance Visual Acuity Under Mesopic Conditions | Visual acuity measured at 4 m | Posted | Mean | Standard Deviation | logMAR | 3 months after surgery |
|
|
|
| 0 |
| 31 |
| 0 |
| 31 |
| 0 |
| 31 |
| EG001 | Clareon Vivity IOL | The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. Vivity IOL: The Vivity IOL is a lens that provides extended range of vision ranging from distance to near reducing the need for glasses after routine cataract surgery in patients with or without astigmatism. | 0 | 31 | 0 | 31 | 0 | 31 |
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