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This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| non-toric intraocular lens | Active Comparator | non-toric approved intraocular lens |
|
| toric intraocular lens | Active Comparator | approved toric intraocular lens |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-toric intraocular lens | Device | TECNIS One-piece Monofocal Model ZCB00 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of Severe Visual Distortions | The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available. | 6 months |
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Inclusion Criteria:
Minimum 22 years of age
Bilateral cataracts
Preoperative keratometric cylinder in both eyes
Most appropriate toric IOL model choice (ZCT300 or ZCT400)
Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
Clear intraocular media other than cataract in each eye
Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
Signed informed consent and HIPAA authorization
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devi Priya Janakiraman, OD, FAAO | Johnson & Johnson Surgical Vision | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eye Center South | Dothan | Alabama | 36301 | United States | ||
| Arizona Eye Cente |
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| ID | Title | Description |
|---|---|---|
| FG000 | Toric IOL | Experimental (ZCT300, ZCT400) |
| FG001 | Non-toric IOL | Control (ZCB00) |
| 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 | May 21, 2018 | Dec 10, 2019 |
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| toric intraocular lens |
| Device |
TECNIS One-piece Toric Models ZCT300 or ZCT400 |
|
| Chandler |
| Arizona |
| 85225 |
| United States |
| Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente | Tucson | Arizona | 85704 | United States |
| Boozman-Hof Regional Eye Clinic | Rogers | Arkansas | 72757 | United States |
| Empire Eye & Laser Center | Bakersfield | California | 93309 | United States |
| Atlantis Eye Care | Huntington Beach | California | 92647 | United States |
| Scripps Clinic Medical Group | La Jolla | California | 92037 | United States |
| Southern California Eye Physicians & Associates | Long Beach | California | 90805 | United States |
| Feinerman Vision Center | Newport Beach | California | 92663 | United States |
| Coastal Vision | Orange | California | 92868 | United States |
| California Eye Medical Specialists | Pasadena | California | 91107 | United States |
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States |
| Florida Eye Microsurgical Institute, Inc. | Boynton Beach | Florida | 33426 | United States |
| Katzen Eye Care & Laser Center | Boynton Beach | Florida | 33426 | United States |
| The Eye Associates | Bradenton | Florida | 34209 | United States |
| Cape Coral Eye Center | Cape Coral | Florida | 336904 | United States |
| Levenson Eye Associates, Inc. | Jacksonville | Florida | 32204 | United States |
| Northwestern University Feinberg School of Medicine | Chicago | Illinois | 60611 | United States |
| Virdi Eye Clinic & Laser Vision Center | Rock Island | Illinois | 61201 | United States |
| Senior Health Services | Louisville | Kentucky | 40220 | United States |
| Chesapeake Eye Care and Laser Center | Annapolis | Maryland | 21401 | United States |
| Solomon Eye Associates | Bowie | Maryland | 20716 | United States |
| Eye Doctors of Washington | Chevy Chase | Maryland | 20815 | United States |
| Oakland Ophthalmic Surgery, P.C. | Birmingham | Michigan | 48009 | United States |
| TLC Eye Care and Laser Centers | Chelsea | Michigan | 48118 | United States |
| Mercy Clinic Eye Specialist | Springfield | Missouri | 65804 | United States |
| Ophthalmology Associates | St Louis | Missouri | 63131 | United States |
| Ophthalmology Consultants | St Louis | Missouri | 63131 | United States |
| Kindermann Eye Associates | Cherry Hill | New Jersey | 08002 | United States |
| Matossian Eye Associates | Pennington | New Jersey | 08534 | United States |
| Eye Associates of New Mexico | Albuquerque | New Mexico | 87109 | United States |
| Pamel Vision & Laser Group | New York | New York | 10065 | United States |
| Fine, Hoffman & Sims | Eugene | Oregon | 97401 | United States |
| The Eye Center of Central PA | Allenwood | Pennsylvania | 17810 | United States |
| Ludwick Eye Center | Chambersburg | Pennsylvania | 17201 | United States |
| Scott & Christie and Associates, PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Carolina Cataract & Laser Center | Ladson | South Carolina | 29456 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57105 | United States |
| Loden Vision Centers | Goodlettsville | Tennessee | 37072 | United States |
| Houston Eye Associates | Houston | Texas | 77025 | United States |
| Whitsett Vision Group | Houston | Texas | 77055 | United States |
| Focal Point Vision | San Antonio | Texas | 78229 | United States |
| San Antonio Eye Specialists | San Antonio | Texas | 78248 | United States |
| Clarus Eye Centre | Lacey | Washington | 98503 | United States |
| COMPLETED |
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| NOT COMPLETED |
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All subjects who have at least one eye implanted with the study IOL (Toric or control) are included in the demographic analysis. For questionnaire results only subjects who were bilaterally implanted with study IOL (Toric or control) were included.
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| ID | Title | Description |
|---|---|---|
| BG000 | Toric IOL | Experimental (ZCT300, ZCT400) |
| BG001 | Non-toric IOL | Control (ZCB00) |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| 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 Severe Visual Distortions | The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available. | All subjects bilaterally implanted with a toric IOL (ZCT300 or ZCT400) and all subjects bilaterally implanted with a control IOL (ZCB00). All subjects who were monocularly implanted with a toric IOL (ZCT300/400) or control were excluded from the analysis. | Posted | Count of Participants | Participants | 6 months |
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All AEs were reported and followed until resolution with a timeframe of 6 months. Subjects who reported IOL repositioning or severe visual distortion on the 6 month visit were followed up until 1 year 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 | Toric IOL | Experimental (ZCT300, ZCT400) | 1 | 214 | 32 | 214 | 0 | 214 |
| EG001 | Non-toric IOL | Control (ZCB00) | 2 | 151 | 16 | 151 | 1 | 151 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lens repositioning | Surgical and medical procedures | Systematic Assessment |
| ||
| Epiretinal membrane with significant Vitreo-Retinal traction | Eye disorders | Systematic Assessment |
| ||
| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
| ||
| Macular Hole | Eye disorders | Systematic Assessment |
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| Clinically Significant Macular Edema | Eye disorders | Systematic Assessment |
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| Residual Cortical material | Surgical and medical procedures | Systematic Assessment |
| ||
| Elevated intraocular pressure requiring treatment | Eye disorders | Systematic Assessment |
| ||
| Capsular Rupture | Eye disorders | Systematic Assessment |
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| Retinal Detachment | Eye disorders | Systematic Assessment |
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| Hyphema | Eye disorders | Systematic Assessment |
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| Macular Edema | Eye disorders | Systematic Assessment |
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| Capsular Tear | Eye disorders | Systematic Assessment |
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| Vitreous Strand | Eye disorders | Systematic Assessment |
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| Hospitalization | General disorders | Systematic Assessment |
| ||
| Prostate Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
| ||
| Breast Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Death | General disorders | Systematic Assessment |
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| Crerebrovascular Accident | Vascular disorders | Systematic Assessment |
| ||
| Ulcerative Colitis | Gastrointestinal disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cystoid Macular Edema | Eye disorders | Systematic Assessment |
|
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at any time.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devi Priya Janakiraman, OD, FAAO | Johnson & Johnson Surgical Vision | +1 714 247- 8628 | djanaki1@its.jnj.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jun 24, 2015 | Dec 10, 2019 | SAP_001.pdf |
| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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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