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This study is a 6-month, prospective, multicenter, bilateral, randomized clinical investigation of the TECNIS Model ZHR00 and Model ZQR00 IOLs versus the TECNIS Symfony control IOL.
The study was conducted at 12 sites in the U.S.A and treated approximately 240 subjects, equally split between the two test groups and the control group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Lens Device #1 | Other | Investigational Intraocular Lens Device #1: Tecnis Model ZHR00 |
|
| Investigational Lens Device #2 | Other | Investigational Intraocular Lens Device #2: Tecnis Model ZQR00 |
|
| Control Device | Other | Control TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Intraocular Lens Device #1: TECNIS Model ZHR00 | Device | Intraocular lens replaces the natural lens removed during cataract surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative | 1 month postoperative |
| Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | 6 months postoperative |
| Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | 6 months postoperative |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devi Priya Janakiraman, OD,FAAO | Abbott Medical Optics | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Empire Eye and Laser Center | Bakersfield | California | 93309 | United States | ||
| Assil Eye Institute |
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A total of 242 subjects were enrolled in this study, and 229 subjects were implanted with study IOL in first eye.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tecnis ZHR00 | Investigational Lens Device |
| FG001 | Tecnis ZQR00 | Investigational Lens Device |
| 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 | Feb 24, 2017 | Jul 6, 2020 |
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subject/evaluator-masked
| Investigational Intraocular Lens Device #2: TECNIS Model ZQR00 | Device | Intraocular lens replaces the natural lens removed during cataract surgery. |
|
| TECNIS Symfony® Extended Range of Vision Intraocular Lens: Model ZXR00 | Device | Intraocular lens replaces the natural lens removed during cataract surgery. |
|
| Beverly Hills |
| California |
| 90210 |
| United States |
| Jones Eye Care | Sioux City | Iowa | 51104 | United States |
| Chesapeake Eye Care and Laser | Annapolis | Maryland | 21401 | United States |
| Eye Doctors of Washington | Chevy Chase | Maryland | 20815 | United States |
| Ophthalmology Consultants LTD | St Louis | Missouri | 63131 | United States |
| Scott and Christie and Associates,PC | Cranberry Township | Pennsylvania | 16066 | United States |
| Carolina Cataract and Laser Center | Ladson | South Carolina | 29456 | United States |
| Vance Thompson Vision | Sioux Falls | South Dakota | 57108 | United States |
| Loden Vision Centers | Goodlettsville | Tennessee | 37072 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 75243 | United States |
| Texas Eye and Laser Center | Hurst | Texas | 76054 | United States |
| FG002 |
| Tecnis ZXR00 |
Control Lens Device |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tecnis ZHR00 | Investigational Lens Device |
| BG001 | Tecnis ZQR00 | Investigational Lens Device |
| BG002 | Tecnis ZXR00 | Control Lens Device |
| BG003 | 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, Customized | Number | Participants |
| ||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | 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 | Monocular Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | The primary effectiveness endpoint is mean (LogMAR), photopic, monocular, first-eye, distance corrected near visual acuity (40 cm) at 1 month postoperative | The safety population (SP) of all subjects implanted who have available data will be used for all analysis. For the monocular endpoints, the safety population will consist of first eyes implanted with a study IOL. | Posted | Mean | Standard Deviation | LogMAR | 1 month postoperative | Eyes | Eyes |
|
|
| |||||||||||||||||||||||||||||||
| Primary | Rates of Adverse Events vs ISO (International Organization for Standardization) SPE ( Safety and Performance Endpoint) Rates (6-Month Persistent Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO (International Organization for Standardization) SPE (Safety and performance Endpoint) rates using a one-sided, exact test based on the binomial distribution. ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). ISO 11979-7 is a document that specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia. SPE rate: safety and performance endpoint (rate derived from analysis of the data from clinical investigations of IOLs approved in the US). Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | Statistical comparisons to ISO SPE rates are based on first-eye data | Posted | Number | Percent | 6 months postoperative |
| ||||||||||||||||||||||||||||||||||||
| Primary | Rates of Adverse Events vs ISO SPE Rates (6-Month Cumulative Medical Complications/Adverse Events vs ISO 11979-9 SPE Rates) | Adverse Event rates for the Models ZHR00 and ZQR00 investigational lens first eyes are compared to the ISO SPE rates using a one-sided, exact test based on the binomial distribution. Only AE rates that are higher than ISO SPE rate value are required to do statistical comparison. Any AE rate that is below ISO SPE value, statistical testing is not necessary to see if the rate is significantly higher than ISO. | Statistical comparisons to ISO SPE rates are based on first-eye data | Posted | Number | Percent | 6 months postoperative |
|
|
6 months
The frequency and proportion of first eyes, second eyes and all subjects with these events is reported by IOL group.
One subject had ZQR00 implanted in first eye and ZHR00 in second eye. For AE table this subject is included in both the ZQR00 and ZHR00 population group.
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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 ZHR00 | Investigational Lens Device | 2 | 78 | 8 | 78 | 4 | 78 |
| EG001 | ZQR00 | Investigational Lens Device | 0 | 73 | 7 | 73 | 3 | 73 |
| EG002 | ZXR00 | Control Lens Device | 1 | 79 | 5 | 79 | 3 | 79 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal tear and repair | Eye disorders | Non-systematic Assessment |
| ||
| Blood Clot in leg requiring emergency angioplasty | Vascular disorders | Non-systematic Assessment |
| ||
| Secondary Surgical Intervention: IOL removal | Product Issues | Non-systematic Assessment |
| ||
| Cystoid Macular Edema | Eye disorders | Non-systematic Assessment |
| ||
| Lung Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
| ||
| Hernia Surgical repair | Surgical and medical procedures | Non-systematic Assessment |
| ||
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
| ||
| Diverticulitis of Large intestine with perforation resulting in hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
| ||
| Lens removal due to undesired optical phenomena due to fixed pupil | Eye disorders | Non-systematic Assessment |
| ||
| Heart Attack | Cardiac disorders | Non-systematic Assessment |
| ||
| Death during sleep | General disorders | Non-systematic Assessment |
| ||
| Hospitalization due to surgical removal of tumors | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Death secondary to cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hospitalization due to weakness secondary to cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment |
| ||
| Hospitalization due to hip fracture secondary to fall | Injury, poisoning and procedural complications | Non-systematic Assessment |
| ||
| Hospitalization due to cholecystectomy | Surgical and medical procedures | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| ADE, Bothersome visual symptoms causing significant impairment lasting more than 3 mos postop | Product Issues | Non-systematic Assessment |
|
The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.
| 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 | Feb 24, 2017 | Jul 6, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| 60-69 years |
|
| 70-79 years |
|
| Greater than or equal to >= 80 years |
|
| Not reported |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Black |
|
| Native Hawaiian/Pacific Islander |
|
| Caucasian |
|
| Other race |
|
| Not Reported |
|
| OG002 | Tecnis ZXR00 | Control Lens Device |
|
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