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| Name | Class |
|---|---|
| Science in Vision | OTHER |
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This is a single visit study to evaluate the visual outcomes and patient satisfaction of patients who were bilaterally implanted with the Tecnis Synergy IOL between June 1 and December 31, 2021 in 2 centers in USA
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Synergy IOL | Patients implanted with the Synergy IOL in both eyes. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tecnis Synergy IOL | Device | Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Photopic Conditions | Visual acuity measured at 40 cm | Up to 1 year |
| Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions | Visual acuity measured at 40 cm under dim light | Up to 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who underwent routine, uneventful cataract surgery with implantation of the Synergy lens in both eyes between 01June2021 and 31Dec2021 at Center For Sight (Sarasota, FL) and Carolina Eyecare Physicians (Charleston, SC)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center For Sight | Venice | Florida | 34285 | United States | ||
| Carolina Eyecare Physicians |
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| ID | Title | Description |
|---|---|---|
| FG000 | Synergy IOL | Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Synergy IOL | Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
| 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 Participants |
| 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 Near Visual Acuity at 40 cm Under Photopic Conditions | Visual acuity measured at 40 cm | Posted | Mean | Standard Deviation | logMAR | Up to 1 year |
|
|
Day of study visit
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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 | Synergy IOL | Patients implanted with the Synergy IOL in both eyes. Tecnis Synergy IOL: Intraocular lens replaces the natural lens removed during cataract surgery in both eyes. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Research | Center For Sight | 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 | May 3, 2022 | Aug 28, 2023 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D011305 | Presbyopia |
| D019591 | Pseudophakia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Mt. Pleasant |
| South Carolina |
| 29464 |
| United States |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Primary | Binocular Distance Corrected Near Visual Acuity at 40 cm Under Mesopic Conditions | Visual acuity measured at 40 cm under dim light | Posted | Mean | Standard Deviation | logMAR | Up to 1 year |
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| 0 |
| 52 |
| 0 |
| 52 |
| 0 |
| 52 |
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