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An investigational IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month study.
The next generation TECNIS IOL designed to provide improved intermediate and near visual acuity and decreased spectacle wear was evaluated for safety and effectiveness in a six-month interventional study and compared to a marketed monofocal IOL. Assessments included distance-corrected intermediate and near visual acuity, depth of focus at 0.2 logMAR and spectacle wear frequency.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Investigational Device: Next Generation TECNIS IOL | Experimental | Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL |
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| Control Device: TECNIS Monofocal IOL | Active Comparator | Control Monofocal Intraocular Lens: TECNIS Monofocal IOL |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Investigational Intraocular Lens Device #1: Next Generation TECNIS IOL | Device | Intraocular lens replaces the natural lens removed during cataract surgery. |
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| Measure | Description | Time Frame |
|---|---|---|
| Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only. | 6 months (postoperative) |
| Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only. | 6 months (postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Devi Priya Janakiraman, OD, FAAO | Johnson & Johnson Surgical Vision, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wolstan & Goldberg Eye Associates | Torrance | California | 90505 | United States | ||
| The Eye Associates of Manatee, LLP |
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Total of 247 participants signed the informed consent form and out of them 27 participants were never randomized and treated, 2 were randomized but not treated. Hence 218 participants were implanted lens in the first eye, (110 in ZHR00 and 108 in ZCB00 control group).
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| ID | Title | Description |
|---|---|---|
| FG000 | Investigational Device: ZHR00 | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| FG001 | Control Device: 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 | Apr 1, 2019 | May 29, 2020 |
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| Control Monofocal Intraocular Lens: TECNIS Monofocal IOL | Device | Intraocular lens replaces the natural lens removed during cataract surgery. |
|
| 6 months (postoperative) |
| Overall Spectacle Wear | Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time". | 6 months (postoperative) |
| Bradenton |
| Florida |
| 34209 |
| United States |
| Levenson Eye Associates, Inc. | Jacksonville | Florida | 32204 | United States |
| Jones Eye Clinic | Sioux City | Iowa | 51104 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Eye Care Specialists | Kingston | Pennsylvania | 18704 | United States |
| Vance Thompson Vision Clinic, Prof LLC | Sioux Falls | South Dakota | 57108 | United States |
| Key-Whitman Eye Center | Dallas | Texas | 11442 | United States |
| Berkeley Eye Institute, P.A. | Houston | Texas | 77027 | United States |
| Slade & Baker Vision | Houston | Texas | 77027 | United States |
TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| First Eye |
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| Second Eye |
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| COMPLETED |
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| NOT COMPLETED |
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The modified intent-to-treat (mITT) population included all eyes randomized and implanted with either a test or control study intraocular lens (IOL) in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Investigational Device: ZHR00 | Investigational next-generation TECNIS foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| BG001 | Control Device: ZCB00 | TECNIS control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes who planned to have bilateral cataract surgery. |
| 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, 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Primary | Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only. | The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. | Posted | Mean | Standard Deviation | logMAR | 6 months (postoperative) | Eyes | Eyes |
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| Primary | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | Depth of focus was assessed using best corrected distance refraction, and 100% contrast ETDRS letters. VA was measured between +2.00 Diopter (D) and -4.00 D in 0.5 D defocus steps. VA was measured in logMAR. The depth of focus was estimated as the dioptric range between zero defocus and the first point on the negative lens induced mean defocus curve that crosses the 0.2 logMAR using a linear interpolation. A lower numeric value represents better VA. This analysis was pre-specified to be reported for the first operative eye only. | The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. | Posted | Mean | Full Range | diopter | 6 months (postoperative) | Eyes | Eyes |
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| Secondary | Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | Visual acuity was tested monocularly under photopic conditions using best distance correction (distance refraction) and high contrast, ETDRS chart set at 40 cm from the spectacle plane using the near point rod. VA was measured in logMAR on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified to be reported for the first operative eye only. | The safety (SF) population included all eyes and subjects implanted in at least one eye with either a test or control IOL with data available at the time of analysis (i.e., no data imputation). Here 'N' (number of participants and number of eyes analyzed) signifies the number of participants and their first eye evaluated for this outcome measure. | Posted | Mean | Standard Deviation | LogMAR | 6 months (postoperative) | Eyes | Eyes |
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| Secondary | Overall Spectacle Wear | Overall spectacle wear was determined for participants wearing glasses or contact lenses using Patient-Reported Spectacle Independence Questionnaire (PRSIQv2) asking if their response is 'none of the time' in all the 4 conditions (distance vision, intermediate vision, near vision and overall vision) of the spectacle wear questions were reported. PRSIQv2 questionnaire responses were divided into two response groups: reports of "none of the time" and the combined reports of "a little of the time," "some of the time," "most of the time," or "all of the time". | The modified intent-to-treat (mITT) population included all eyes randomized and implanted with either a test or control study intraocular lens (IOL) in the study. Here 'N' (number of participants analyzed) signifies participants who were evaluable for this outcome measure. | Posted | Number | Percentage of participants | 6 months (postoperative) |
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Up to 11.5 months
The SF population included all eyes and participants implanted in at least one eye with either a test or control IOL with data available at the time of analysis (that is, no data imputation). Adverse events (AEs) were planned to be reported for each eye separately and AEs not related to eyes were counted and represented in both the eyes.
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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 | Investigational Device: ZHR00 (First Eye) | Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | 0 | 110 | 5 | 110 | 9 | 110 |
| EG001 | Control Device: ZCB00 (First Eye) | Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | 0 | 108 | 5 | 108 | 1 | 108 |
| EG002 | Investigational Device: ZHR00 (Second Eye) | Investigational next-generation tecnis symfony, model ZHR00 foldable intra ocular lens (IOL) designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | 0 | 109 | 6 | 109 | 9 | 109 |
| EG003 | Control Device: ZCB00 (Second Eye) | Investigational next-generation tecnis control monofocal model ZCB00 foldable IOL designed for placement in the capsular bag were implanted in participants eyes to have cataract surgery using the unfolder platinum 1 series implantation system. | 0 | 108 | 4 | 108 | 1 | 108 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | Non-systematic Assessment |
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| Cystoid macular edema | Eye disorders | Non-systematic Assessment |
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| Lens dislocation | Product Issues | Non-systematic Assessment |
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| Hypopyon | Eye disorders | Non-systematic Assessment |
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| Cortical Remnant in anterior chamber | Surgical and medical procedures | Non-systematic Assessment |
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| Hospitalization for vomiting | Gastrointestinal disorders | Non-systematic Assessment |
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| Atherosclerosis with intermittent claudication | Vascular disorders | Non-systematic Assessment |
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| Hospitalization for Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Hospitalization for myocardial infarction | Cardiac disorders | Non-systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Adverse Device Effects due to visual symptoms | Product Issues | 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 | |
|---|---|---|---|---|
| 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 | Apr 2, 2019 | May 29, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D002386 | Cataract |
| ID | Term |
|---|---|
| D007905 | Lens Diseases |
| D005128 | Eye Diseases |
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| Title | Measurements |
|---|---|
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| 70-79 Years |
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| Greater than or equal to >= 80 Years |
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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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| Black |
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| Native Hawaiian/Pacific Islander |
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| Caucasian |
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| Other Race |
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| American Indian/Alaska Native |
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| Not Reported |
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| Units | Counts |
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| Participants |
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| Eyes |
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