Cataract, Corneal Astigmatism
Conditions
Brief summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative, 6-month clinical study conducted at up to 50 sites in the USA.
Interventions
DEVICEHigher Cylinder Toric IOL
Symfony Toric models ZXT300 and ZXT375 IOL
DEVICELower Cylinder Toric IOL
Symfony Toric model ZXT150 IOL
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
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 * have a certain degree of astigmatism in at least one eye * 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 Both eyes must qualify to be eligible to participate in the study
Exclusion criteria
* Currently participating in any other clinical study or have participated in a clinical study during the last 30 days * Have a certain disease/illness such as poorly-controlled diabetes * Have certain ocular conditions such as uncontrolled glaucoma * Taking medication that may affect subject vision * Have irregular corneal astigmatism * Pregnant, plan to become pregnant during the study, or is breastfeeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Bothersome Visual Symptoms | 6-month | The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire. |
| Rate of Difficulty With an Activity Due to the Visual Symptoms | 6-month | The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire. |
Countries
United States
Participant flow
Pre-assignment details
It includes all subjects with ZXT300/375/150 toric IOL in the primary eye.
Participants by arm
| Arm | Count |
|---|---|
| Higher Cylinder Group All subjects implanted with a higher cylinder IOL (ZXT300 or ZXT375) in the primary eye. | 260 |
| Lower Cylinder Group All subjects implanted with a lower cylinder IOL (ZXT150) in the primary eye. | 215 |
| Total | 475 |
Baseline characteristics
| Characteristic | Lower Cylinder Group | Total | Higher Cylinder Group |
|---|---|---|---|
| Age, Continuous | 68.2 Years STANDARD_DEVIATION 7.9 | 68.7 Years STANDARD_DEVIATION 8.9 | 69.2 Years STANDARD_DEVIATION 9.8 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 12 Participants | 20 Participants | 8 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 20 Participants | 12 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 4 Participants | 3 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 194 Participants | 431 Participants | 237 Participants |
| Sex: Female, Male Female | 134 Participants | 285 Participants | 151 Participants |
| Sex: Female, Male Male | 81 Participants | 190 Participants | 109 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 260 | 2 / 215 |
| other Total, other adverse events | 12 / 260 | 2 / 215 |
| serious Total, serious adverse events | 34 / 260 | 33 / 215 |
Outcome results
Primary
Rate of Bothersome Visual Symptoms
The rate of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via questionnaire.
Time frame: 6-month
Population: Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Higher Cylinder Group | Rate of Bothersome Visual Symptoms | 19 Participants |
| Lower Cylinder Group | Rate of Bothersome Visual Symptoms | 19 Participants |
Primary
Rate of Difficulty With an Activity Due to the Visual Symptoms
The rate of reported difficulty with an activity due to one or more of visual symptoms impacting daily life via questionnaire.
Time frame: 6-month
Population: Higher cylinder includes all bilaterally implanted subjects with at least a ZXT300 or ZXT375 in the primary eye; lower cylinder group includes all bilaterally implanted subjects with ZXT150 in the primary eye.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Higher Cylinder Group | Rate of Difficulty With an Activity Due to the Visual Symptoms | 28 Participants |
| Lower Cylinder Group | Rate of Difficulty With an Activity Due to the Visual Symptoms | 26 Participants |