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This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Higher Cylinder Toric IOL | Active Comparator | Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. |
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| Lower Cylinder Toric IOL | Active Comparator | Consented subjects that are eligible will have both eyes implanted with a TECNIS Symfony IOL. Each eye may have a different TECNIS Symfony IOL implanted, as determined by the surgeon and the TECNIS Symfony Toric IOL calculator; however, at least one eye must be implanted with either a Symfony Toric IOL Model ZXT150 (lower-cylinder group) or a Model ZXT300 or ZXT375 (higher-cylinder group) and the fellow eye must have the same or a lower toric power. The eye with the highest toric power IOL will determine the model group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Higher Cylinder Toric IOL | Device | Symfony Toric models ZXT300 and ZXT375 IOL |
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| Measure | Description | Time Frame |
|---|---|---|
| Rate of Bothersome Visual Symptoms | The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. | 6-month |
| Rate of Difficulty With an Activity Due to the Visual Symptoms | The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire. | 6-month |
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Inclusion Criteria:
Both eyes must qualify to be eligible to participate in the study
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States | ||
| Southern California Eye Physicians & Associates |
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It includes all subjects with ZXT300/375/150 toric IOL in the primary eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Higher Cylinder Group | All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. |
| FG001 | Lower Cylinder Group | All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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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 | Nov 15, 2018 | Jul 7, 2023 |
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| Lower Cylinder Toric IOL |
| Device |
Symfony Toric model ZXT150 IOL |
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| Long Beach |
| California |
| 90805 |
| United States |
| Santa Monica Eye Medical Group | Santa Monica | California | 90404 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | 33426 | United States |
| The Eye Associates of Manatee | Bradenton | Florida | 34209 | United States |
| Levenson Eye Associates | Jacksonville | Florida | 32204 | United States |
| North Florida Eye Surgeons, LLC dba Florida Eye Specialist | Jacksonville | Florida | 32256 | United States |
| Center For Sight | Sarasota | Florida | 34239 | United States |
| Virdi Eye Clinic & Laser Vision Care | Rock Island | Illinois | 61201 | United States |
| Chesapeake Eye Care & Laser | Annapolis | Maryland | 21401 | United States |
| Oakland Ophthalmic Surgery | Birmingham | Michigan | 48009 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63128 | United States |
| Northern New Jersey Eye Institute PA | South Orange | New Jersey | 07079 | United States |
| Ludwick Eye Center | Chambersburg | Pennsylvania | 17201 | United States |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Memphis Eye & Cataract Associates, PLLC | Memphis | Tennessee | 38119 | United States |
| Cornea Associates of Texas | Dallas | Texas | 75231 | United States |
| Texas Eye & Laser Center | Hurst | Texas | 76054 | United States |
| Focal Point Vision | San Antonio | Texas | 78209 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Clarus Eye Centre | Lacey | Washington | 98503 | United States |
| COMPLETED |
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| NOT COMPLETED |
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Higher cylinder group consists of all subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. Lower cylinder group consists of all subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye.
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| ID | Title | Description |
|---|---|---|
| BG000 | Higher Cylinder Group | All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. |
| BG001 | Lower Cylinder Group | All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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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| 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 | Rate of Bothersome Visual Symptoms | The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. | Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye. | Posted | Count of Participants | Participants | 6-month |
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| Primary | Rate of Difficulty With an Activity Due to the Visual Symptoms | The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire. | Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye. | Posted | Count of Participants | Participants | 6-month |
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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 | Higher Cylinder Group | All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. | 0 | 260 | 34 | 260 | 12 | 260 |
| EG001 | Lower Cylinder Group | All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye. | 2 | 215 | 33 | 215 | 2 | 215 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
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| Vitreous Hemorrhage | Eye disorders | Systematic Assessment |
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| Undesirable Optical Phenomena | Eye disorders | Systematic Assessment |
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| Elevated IOP requiring treatment | Eye disorders | Systematic Assessment |
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| Non-Ischemic Optic Neuropathy | Eye disorders | Systematic Assessment |
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| Lens Axis Misalignment requiring SSI | Eye disorders | Systematic Assessment |
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| Retinal Detachment/Tear | Eye disorders | Systematic Assessment |
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| RETINAL VEIN OCCLUSION | Eye disorders | Systematic Assessment |
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| Visual Symptoms requiring SSI | Eye disorders | Systematic Assessment |
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| Tilt & decentration requiring SSI | Eye disorders | Systematic Assessment |
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| IOP Elevated Without Need for Treatment | Eye disorders | Systematic Assessment |
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| Corneal Edema | Eye disorders | Systematic Assessment |
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| Iritis | Eye disorders | Systematic Assessment |
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| IOP Greater than 10mmHg from Screening and More than 25mmHg | Eye disorders | Systematic Assessment |
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| Hospitalization | General disorders | Systematic Assessment |
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| Difficulty Breathing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Cancer | General disorders | Systematic Assessment |
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| Wrist Fracture Surgery | Surgical and medical procedures | Systematic Assessment |
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| Pneumonia/COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Undesirable Optical Phenomena | Eye disorders | Systematic Assessment |
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The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Luis Vargas, MD | Johnson & Johnson Surgical Vision | 714-247-8200 | LVarga17@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2021 | Jul 7, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| D001251 | Astigmatism |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
| D012030 | Refractive Errors |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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