Cataract, Corneal Astigmatism
Conditions
Brief summary
This study will be a prospective, multicenter, bilateral, comparative, three-way masked (Sponsor, subject and evaluator), randomized clinical investigation conducted at up to 15 sites. Up to 300 subjects will be enrolled to achieve approximately 270 bilaterally implanted subjects, resulting in approximately 244 evaluable subjects (122 per lens group) at 6 months. After informed consent is obtained and confirmation that all eligibility criteria are met, the eye(s) may be treated according to randomization. After signing the informed consent form, subjects meeting all eligibility criteria will be randomized in a masked fashion to a treatment group: either the investigational IOL Model ZFR00V or the control IOL Model ZCB00. Prior to randomization, the investigator will choose which eye to operate on first for each subject at his/her discretion based on his/her standard clinical practice (e.g., the eye with the worse cataract, poorer best corrected distance vision and/or more severe optical/visual complaints). All subjects are intended to have bilateral cataract surgery with the second eye surgery occurring after the 1-week postoperative exam for the first eye, but no more than 30 days after the first eye surgery. All subjects will be examined through 6 months postoperatively according to the visit schedule
Interventions
DEVICEIOL Model ZFR00V
Bilateral implantation with Investigational IOL Model ZFR00V
DEVICEIOL Model ZCB00
Bilateral Implantation with control IOL Model ZCB00
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Only the surgeon and the operative staff will know which lens type is implanted and will be unmasked throughout the study. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study staff and study subjects will be instructed not to disclose the lens type the subject received or to talk about the lens to any subjects or masked evaluators. The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject/technician-masking through the 6-month study exams, a masking plan will be tailored for each site to detail how lens assignment information will be concealed from masked technicians.
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* be at least 22 years old * have cataracts in both eyes * sign the written informed consent * be willing and able to comply with examination procedures * understand, read and write English to complete informed consent and questionnaires * be available for study follow-up visits
Exclusion criteria
* currently participating in any other clinical study or have participated in a clinical study during the last 60 days * have a certain disease/illness such as poorly-controlled diabetes * have certain ocular conditions such as uncontrolled glaucoma * Is taking medication that may affect vision * Subject is pregnant, plan to become pregnant during the study, or is breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm | 6 months (postoperative) | mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm | 6 months (postoperative) | mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population |
| Monocular Distance-Corrected Near Visual Acuity at 33 cm | 6 months postoperative | mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months |
| Monocular Photopic Best-Corrected Distance Visual Acuity | 6 months postoperative | mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population. |
| Monocular Distance-Corrected Defocus Curve | 6 months postoperative | Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population |
| Spectacle Wear | 6 months postoperative | Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts none of the time in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative. |
Countries
United States
Participant flow
Pre-assignment details
272 subjects were bilaterally implanted with either the study or control lens. 135 subjects were bilaterally implanted with the study lens and 137 subjects were bilaterally implanted with the control lens. All 272 subjects were bilaterally implanted with the same IOL model in both eyes.
Participants by arm
| Arm | Count |
|---|---|
| ZFR00V Study Lens | 135 |
| ZCB00 Control Lens | 137 |
| Total | 272 |
Baseline characteristics
| Characteristic | ZFR00V | ZCB00 | Total |
|---|---|---|---|
| Age, Customized <60 | 17 Participants | 17 Participants | 34 Participants |
| Age, Customized 60 to 69 | 50 Participants | 57 Participants | 107 Participants |
| Age, Customized 70 to 79 | 62 Participants | 56 Participants | 118 Participants |
| Age, Customized > or = 80 | 6 Participants | 7 Participants | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 7 Participants | 15 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 127 Participants | 130 Participants | 257 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian (including Indian) | 3 Participants | 1 Participants | 4 Participants |
| Race/Ethnicity, Customized Black | 15 Participants | 19 Participants | 34 Participants |
| Race/Ethnicity, Customized Caucasian | 114 Participants | 116 Participants | 230 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Other Race | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Female | 94 Participants | 90 Participants | 184 Participants |
| Sex: Female, Male Male | 41 Participants | 47 Participants | 88 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 / 135 | 0 / 137 | 0 / 135 | 0 / 137 |
| other Total, other adverse events | 10 / 135 | 0 / 137 | 0 / 135 | 0 / 137 |
| serious Total, serious adverse events | 6 / 135 | 2 / 137 | 8 / 135 | 3 / 137 |
Outcome results
Primary
Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm
mean photopic monocular Distance Corrected Near Visual Acuity results at 40 cm for ZFR00 and control first eyes in the safety population at 6 months
Time frame: 6 months (postoperative)
Population: The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZFR00V | Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.104 LogMAR | Standard Deviation 0.138 |
| ZCB00 | Distance-Corrected Near Visual Acuity (DCNVA) at 40 cm | 0.522 LogMAR | Standard Deviation 0.193 |
p-value: <0.0001t-test, 1 sided
Secondary
Monocular Distance-Corrected Defocus Curve
Mean monocular (first eye) distance-corrected defocus curve for each lens group at 6 months in the safety population
Time frame: 6 months postoperative
Population: The safety (SP) population for monocular Distance-Corrected Defocus Curve include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) |
|---|---|---|
| ZFR00V | Monocular Distance-Corrected Defocus Curve | -3.3 diopter |
| ZCB00 | Monocular Distance-Corrected Defocus Curve | -0.9 diopter |
Secondary
Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm
mean photopic monocular Distance-Corrected Intermediate Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population
Time frame: 6 months (postoperative)
Population: The safety (SP) population for monocular Distance-Corrected Intermediate Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZFR00V | Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm | 0.060 LogMAR | Standard Deviation 0.115 |
| ZCB00 | Monocular Distance-Corrected Intermediate Visual Acuity at 66 cm | 0.335 LogMAR | Standard Deviation 0.155 |
p-value: <0.0001t-test, 1 sided
Secondary
Monocular Distance-Corrected Near Visual Acuity at 33 cm
mean photopic monocular Distance-Corrected Near Visual Acuity results at 33 cm for ZFR00 and control first eyes in the safety population at 6 months
Time frame: 6 months postoperative
Population: The safety (SP) population for monocular Distance-Corrected Near Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZFR00V | Monocular Distance-Corrected Near Visual Acuity at 33 cm | 0.154 LogMAR | Standard Deviation 0.151 |
| ZCB00 | Monocular Distance-Corrected Near Visual Acuity at 33 cm | 0.608 LogMAR | Standard Deviation 0.187 |
p-value: <0.0001t-test, 1 sided
Secondary
Monocular Photopic Best-Corrected Distance Visual Acuity
mean monocular Best-Corrected Distance Visual Acuity results at 6 months for ZFR00 and control first eyes in the safety population.
Time frame: 6 months postoperative
Population: The safety (SP) population for monocular Best-Corrected Distance Visual Acuity include all first eyes implanted with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| ZFR00V | Monocular Photopic Best-Corrected Distance Visual Acuity | -0.014 LogMAR | Standard Deviation 0.087 |
| ZCB00 | Monocular Photopic Best-Corrected Distance Visual Acuity | -0.045 LogMAR | Standard Deviation 0.089 |
95% CI: [-0.053, -0.01]
Secondary
Spectacle Wear
Spectacle wear is determined via the PRO questionnaire instrument and defined as wearing glasses or contacts none of the time in all 4 conditions (distance vision, intermediate vision, near vision and overall vision) at 6 months postoperative.
Time frame: 6 months postoperative
Population: The safety (SP) population for spectacle independence include all subjects implanted bilaterally with either a test or control IOL with data available at 6 months postoperative (i.e., no data imputation)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ZFR00V | Spectacle Wear | Not reported | 0 Participants |
| ZFR00V | Spectacle Wear | None of the time | 115 Participants |
| ZFR00V | Spectacle Wear | A little/Some/Most/All of the time | 16 Participants |
| ZCB00 | Spectacle Wear | None of the time | 4 Participants |
| ZCB00 | Spectacle Wear | A little/Some/Most/All of the time | 127 Participants |
| ZCB00 | Spectacle Wear | Not reported | 0 Participants |
p-value: <0.0001Fisher Exact