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This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS® TORIC II Intraocular Lens (IOL) | Experimental | Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS® TORIC II Intraocular Lens (IOL) | Device | Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II | Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ). | 3 months postoperative |
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Inclusion Criteria:
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 | ||
| Jones Eye Clinic |
Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
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87 subjects signed informed consent in the study. 33 were screen failures and 54 subjects were treated/implanted across 8 clinical sites in the US. Of the 54 subjects treated, 32 subjects were treated bilaterally, and 22 subjects were treated unilaterally.
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| ID | Title | Description |
|---|---|---|
| FG000 | TECNIS Toric II | Study Lens |
| 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_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 20, 2020 |
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| Sioux City |
| Iowa |
| 51104 |
| United States |
| Chesapeake Eye Care and Laser Center | Annapolis | Maryland | 21401 | United States |
| Eye Doctors of Washington | Chevy Chase | Maryland | 20815 | United States |
| Oakland Ophthalmic Surgery, P.C. | Birmingham | Michigan | 48009 | United States |
| Tekwani Vision Center | St Louis | Missouri | 63109 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | United States |
| Key & Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Texas Eye and Laser Center | Hurst | Texas | 76054 | United States |
| Parkhurst NuVision | San Antonio | Texas | 78229 | United States |
| Clarus Eye Center | Lacey | Washington | 98503 | United States |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | TECNIS Toric II | Study Lens |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | 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 | Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II | Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ). | All Toric II Eyes | Posted | Number | 95% Confidence Interval | Percentage of eyes | 3 months postoperative | Eyes | Eyes |
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3 months postoperative
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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 | TECNIS Toric II | Study Lens | 0 | 54 | 6 | 54 | 0 | 54 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization due to bleeding varices | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Hospitalization due to heart attack | Cardiac disorders | Non-systematic Assessment |
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| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
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| Hospitalization | Renal and urinary disorders | Non-systematic Assessment |
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| Hospitalization due to vomiting of blood | Gastrointestinal disorders | Non-systematic Assessment |
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| Hospitalization due to pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eugenia K. Thomas | Johnson & Johnson Surgical Vision | +1 657 2903260 | EThoma39@its.jnj.com |
| Sep 2, 2021 |
| Prot_SAP_000.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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| Title | Measurements |
|---|---|
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| >=80 years |
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| Unknown or Not Reported |
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| Native hawaiian/Pacific islander |
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| Caucasian |
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| Other |
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| Not Reported |
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