Cataract
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInvestigational Intraocular Lens Device #1: Next Generation TECNIS IOL
Intraocular lens replaces the natural lens removed during cataract surgery.
DEVICEControl Monofocal Intraocular Lens: TECNIS Monofocal IOL
Intraocular lens replaces the natural lens removed during cataract surgery.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Minimum 22 years of age * Bilateral cataracts for which posterior chamber IOL implantation has been planned * Corneal astigmatism: * Normal corneal topography * Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits * Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries * Ability to understand and respond to a questionnaire in English
Exclusion criteria
* Irregular corneal astigmatism * Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.) * Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs * Poorly-controlled diabetes * Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes * Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial * Desire for monovision correction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | 6 months (postoperative) | 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. |
| Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | 6 months (postoperative) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 6 months (postoperative) | 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. |
| Overall Spectacle Wear | 6 months (postoperative) | 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. |
Countries
United States
Participant flow
Pre-assignment details
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).
Participants by arm
| Arm | Count |
|---|---|
| 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. | 110 |
| 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. | 108 |
| Total | 218 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Investigational Device: ZHR00 | Total | Control Device: ZCB00 |
|---|---|---|---|
| Age, Customized 60-69 Years | 49 Participants | 98 Participants | 49 Participants |
| Age, Customized 70-79 Years | 43 Participants | 83 Participants | 40 Participants |
| Age, Customized Greater than or equal to >= 80 Years | 3 Participants | 9 Participants | 6 Participants |
| Age, Customized less than < 60 Years | 15 Participants | 28 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 10 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 102 Participants | 207 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized American Indian/Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (including Indian) | 4 Participants | 7 Participants | 3 Participants |
| Race/Ethnicity, Customized Black | 6 Participants | 20 Participants | 14 Participants |
| Race/Ethnicity, Customized Caucasian | 99 Participants | 189 Participants | 90 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Race | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 71 Participants | 146 Participants | 75 Participants |
| Sex: Female, Male Male | 39 Participants | 72 Participants | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 110 | 0 / 108 | 0 / 109 | 0 / 108 |
| other Total, other adverse events | 9 / 110 | 1 / 108 | 9 / 109 | 1 / 108 |
| serious Total, serious adverse events | 5 / 110 | 5 / 108 | 6 / 109 | 4 / 108 |
Outcome results
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Investigational Device: ZHR00 | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | 2.3 diopter |
| Control Device: ZCB00 | Monocular Photopic Distance Corrected Depth of Focus Assessed by the Mean Defocus Curve | 0.8 diopter |
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device: ZHR00 | Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | 0.053 logMAR | Standard Deviation 0.149 |
| Control Device: ZCB00 | Monocular, Photopic Distance Corrected Intermediate Visual Acuity (DCIVA) at 66 Centimeter (cm) | 0.370 logMAR | Standard Deviation 0.173 |
p-value: <0.0001t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Investigational Device: ZHR00 | Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.151 LogMAR | Standard Deviation 0.148 |
| Control Device: ZCB00 | Monocular, Photopic Distance Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.466 LogMAR | Standard Deviation 0.203 |
p-value: <0.0001t-test, 1 sided
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.
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Investigational Device: ZHR00 | Overall Spectacle Wear | 63.3 Percentage of participants |
| Control Device: ZCB00 | Overall Spectacle Wear | 7.6 Percentage of participants |
p-value: <0.00011-sided logistic regression