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This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TECNIS® Toric II | Experimental | Subjects will be implanted in one or both eyes with the study lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TECNIS® Toric II | Device | Toric Intraocular Lens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit | Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method. | 1 week 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 and Laser Center, Inc. | Bakersfield | California | 93309 | United States | ||
| University of California |
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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A total of 125 subjects were enrolled. A total of 202 eyes were implanted with the TECNIS Toric II IOL in at least one eye: 80 subjects were treated bilaterally (77 subjects with study lens on both eyes, 3 subjects with non-study lens on first eye and study lens on second eye) and 45 subjects were treated unilaterally. All implanted subjects were examined through 3-months postoperatively.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecnis Toric II IOl | Study Lens |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecnis Toric II IOL | 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 |
| 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 | Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit | Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method. | All Toric II Eyes with Valid Axis Data | Posted | Number | 95% Confidence Interval | Percentage of Eyes | 1 week postoperative | Eyes | Eyes |
|
|
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 | Tecnis Toric II IOL | Study lens | 0 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial Infarction | Cardiac disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Director of Clinical Science, Ophthalmic Implants | Johnson & Johnson Surgical Vision | 7142478200 | EThoma39@its.jnj.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 | Aug 10, 2020 | May 5, 2022 | Prot_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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| Los Angeles |
| California |
| 92705 |
| United States |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | United States |
| Vance Thompson Vision, ND | West Fargo | North Dakota | 58078 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| JW Eye Associates, P.A. DBA Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Texas Eye & Laser Center, P.A. | Hurst | Texas | 76054 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Eyes |
|
|
| 125 |
| 4 |
| 125 |
| 0 |
| 125 |
| COVID-19 | Infections and infestations | Non-systematic Assessment |
|
| Cystoid Macular Edema | Eye disorders | Non-systematic Assessment |
|
| Pulmonary Bilateral embolism | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
| Hyphema | Eye disorders | Non-systematic Assessment |
|
| Hemorrhagic Choroidal Detachment | Eye disorders | Non-systematic Assessment |
|
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.