Trial Outcomes & Findings for Clinical Investigation of the Next Generation Intraocular Lens (NCT NCT03500198)
NCT ID: NCT03500198
Last Updated: 2020-06-25
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
247 participants
Primary outcome timeframe
6 months (postoperative)
Results posted on
2020-06-25
Participant Flow
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).
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
110
|
108
|
|
Overall Study
First Eye
|
110
|
108
|
|
Overall Study
Second Eye
|
109
|
108
|
|
Overall Study
COMPLETED
|
110
|
107
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
Baseline Characteristics
Clinical Investigation of the Next Generation Intraocular Lens
Baseline characteristics by cohort
| Measure |
Investigational Device: ZHR00
n=110 Participants
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.
|
Control Device: ZCB00
n=108 Participants
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.
|
Total
n=218 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
less than < 60 Years
|
15 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
28 Participants
n=206 Participants
|
|
Age, Customized
60-69 Years
|
49 Participants
n=99 Participants
|
49 Participants
n=107 Participants
|
98 Participants
n=206 Participants
|
|
Age, Customized
70-79 Years
|
43 Participants
n=99 Participants
|
40 Participants
n=107 Participants
|
83 Participants
n=206 Participants
|
|
Age, Customized
Greater than or equal to >= 80 Years
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
71 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
146 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
39 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
72 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
102 Participants
n=99 Participants
|
105 Participants
n=107 Participants
|
207 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Asian (including Indian)
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Black
|
6 Participants
n=99 Participants
|
14 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
99 Participants
n=99 Participants
|
90 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Other Race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 6 months (postoperative)Population: 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.
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.
Outcome measures
| Measure |
Investigational Device: ZHR00
n=110 Eyes
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.
|
Control Device: ZCB00
n=107 Eyes
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.
|
|---|---|---|
|
Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm)
|
0.053 logMAR
Standard Deviation 0.149
|
0.370 logMAR
Standard Deviation 0.173
|
PRIMARY outcome
Timeframe: 6 months (postoperative)Population: 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.
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.
Outcome measures
| Measure |
Investigational Device: ZHR00
n=109 Eyes
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.
|
Control Device: ZCB00
n=106 Eyes
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.
|
|---|---|---|
|
Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve
|
2.3 diopter
Interval 2.1 to 2.6
|
0.8 diopter
Interval 0.7 to 1.0
|
SECONDARY outcome
Timeframe: 6 months (postoperative)Population: 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.
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.
Outcome measures
| Measure |
Investigational Device: ZHR00
n=110 Eyes
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.
|
Control Device: ZCB00
n=106 Eyes
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.
|
|---|---|---|
|
Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm
|
0.151 LogMAR
Standard Deviation 0.148
|
0.466 LogMAR
Standard Deviation 0.203
|
SECONDARY outcome
Timeframe: 6 months (postoperative)Population: 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.
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".
Outcome measures
| Measure |
Investigational Device: ZHR00
n=109 Participants
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.
|
Control Device: ZCB00
n=108 Participants
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.
|
|---|---|---|
|
Overall Spectacle Wear
|
63.3 Percentage of participants
|
7.6 Percentage of participants
|
Adverse Events
Investigational Device: ZHR00 (First Eye)
Serious events: 5 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Device: ZCB00 (First Eye)
Serious events: 5 serious events
Other events: 1 other events
Deaths: 0 deaths
Investigational Device: ZHR00 (Second Eye)
Serious events: 6 serious events
Other events: 9 other events
Deaths: 0 deaths
Control Device: ZCB00 (Second Eye)
Serious events: 4 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Investigational Device: ZHR00 (First Eye)
n=110 participants at risk
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.
|
Control Device: ZCB00 (First Eye)
n=108 participants at risk
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.
|
Investigational Device: ZHR00 (Second Eye)
n=109 participants at risk
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.
|
Control Device: ZCB00 (Second Eye)
n=108 participants at risk
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.
|
|---|---|---|---|---|
|
Eye disorders
Retinal Detachment
|
0.00%
0/110 • 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.
|
1.9%
2/108 • Number of events 2 • 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.
|
0.00%
0/109 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
|
Eye disorders
Cystoid macular edema
|
0.00%
0/110 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
|
Product Issues
Lens dislocation
|
0.00%
0/110 • 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.
|
0.00%
0/108 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
0.00%
0/108 • 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.
|
|
Eye disorders
Hypopyon
|
0.00%
0/110 • 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.
|
0.00%
0/108 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
0.00%
0/108 • 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.
|
|
Surgical and medical procedures
Cortical Remnant in anterior chamber
|
0.91%
1/110 • Number of events 1 • 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.
|
0.00%
0/108 • 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.
|
0.00%
0/109 • 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.
|
0.00%
0/108 • 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.
|
|
Gastrointestinal disorders
Hospitalization for vomiting
|
0.91%
1/110 • Number of events 1 • 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.
|
0.00%
0/108 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
0.00%
0/108 • 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.
|
|
Vascular disorders
Atherosclerosis with intermittent claudication
|
0.00%
0/110 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
0.00%
0/109 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for Pneumonia
|
1.8%
2/110 • Number of events 2 • 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.
|
0.00%
0/108 • 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.
|
1.8%
2/109 • Number of events 2 • 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.
|
0.00%
0/108 • 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.
|
|
Cardiac disorders
Hospitalization for myocardial infarction
|
0.91%
1/110 • Number of events 1 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
0.92%
1/109 • Number of events 1 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Investigational Device: ZHR00 (First Eye)
n=110 participants at risk
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.
|
Control Device: ZCB00 (First Eye)
n=108 participants at risk
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.
|
Investigational Device: ZHR00 (Second Eye)
n=109 participants at risk
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.
|
Control Device: ZCB00 (Second Eye)
n=108 participants at risk
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.
|
|---|---|---|---|---|
|
Product Issues
Adverse Device Effects due to visual symptoms
|
8.2%
9/110 • Number of events 9 • 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.
|
0.93%
1/108 • Number of events 1 • 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.
|
8.3%
9/109 • Number of events 9 • 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.
|
0.93%
1/108 • Number of events 1 • 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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Additional Information
Devi Priya Janakiraman, OD, FAAO
Johnson & Johnson Surgical Vision
Phone: +1 714 247- 8628
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime
- Publication restrictions are in place
Restriction type: OTHER