Cataract
Conditions
Brief summary
This study is a prospective, open-label clinical study of the VERITAS Vision System. The study will be conducted at up to three sites, with minimum 55 eyes and up to 150 eyes to be treated. The investigator or designee will perform the cataract surgery with the VERITAS Vision System on the subjects. The data from the system log files, the questionnaire, the operative report and other medical records will be used to assess the clinical utilization of the VERITAS Vision System.
Interventions
DEVICEVERITAS Vision System
The investigators or designees will perform routine small-incision cataract surgery via phacoemulsification and use the VERITAS Vision system. The Investigator or designee will then complete a questionnaire regarding the clinical use of the VERITAS Vision system. The system log files automatically generated by the VERITAS Vision system after completion of each surgery will be collected.
Sponsors
Johnson & Johnson Surgical Vision, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Minimum 22 years of age. * Cataracts for which cataract extraction and posterior chamber IOL implantation have been planned. * Availability, willingness, ability and sufficient cognitive awareness to comply with study requirements, examination procedures, and visits. * Be willing to provide informed consent and authorization to disclose protected health information or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical procedures in the governing countries.
Exclusion criteria
* Expected surgical difficulties at the time of cataract extraction, which may increase the potential for complications (e.g., persistent bleeding, significant iris damage, uncontrolled intraocular pressure change, or significant vitreous prolapse or loss). * Subjects with only one good eye (e.g. amblyopic condition etc.). * Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects. * History or current use of alpha-1 antagonist medication (e.g., Flomax). * Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated. * Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils). * Is pregnant, or is breast feeding, or intend to become pregnant during the study. * Concurrent participation or expected participation in an interventional (i.e., surgical or pharmaceutical interventional) clinical trial within 14 days prior to study screening.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | 1 day postoperative | Surgeons rated the following Questionnaire items regarding satisfaction with the VERITAS Vision System, using 1 - 5 scale (acceptability considered favorable for scores of 4 and 5, where 4 is Satisfied and 5 is Very Satisfied) |
Countries
El Salvador, United States
Participant flow
Pre-assignment details
A total of 115 eyes of 79 subjects were enrolled and treated at 2 sites by 6 investigators. Of these 79 subjects (115 eyes) , 36 subjects had bilateral (72 eyes) surgeries and 43 subjects had unilateral (43 eyes) surgeries.
Participants by arm
| Arm | Count |
|---|---|
| Veritas Vision System Next Generation Phaco System | 79 |
| Total | 79 |
Baseline characteristics
| Characteristic | Veritas Vision System |
|---|---|
| Age, Customized 30-39 years | 0 Participants |
| Age, Customized <30 years | 0 Participants |
| Age, Customized 40-49 years | 2 Participants |
| Age, Customized 50-59 years | 17 Participants |
| Age, Customized 60-69 years | 32 Participants |
| Age, Customized >=70 years | 28 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Asian | 2 Participants |
| Race/Ethnicity, Customized Black | 0 Participants |
| Race/Ethnicity, Customized Caucasian | 36 Participants |
| Race/Ethnicity, Customized Central and South American | 41 Participants |
| Race/Ethnicity, Customized Native Hawaiian/Pacific Islander | 0 Participants |
| Race/Ethnicity, Customized Other race | 0 Participants |
| Sex: Female, Male Female | 57 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 79 |
| other Total, other adverse events | 0 / 79 |
| serious Total, serious adverse events | 1 / 79 |
Outcome results
Primary
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Surgeons rated the following Questionnaire items regarding satisfaction with the VERITAS Vision System, using 1 - 5 scale (acceptability considered favorable for scores of 4 and 5, where 4 is Satisfied and 5 is Very Satisfied)
Time frame: 1 day postoperative
Population: All Eyes treated with Veritas Vision System~\* 1 Surgeon rating was disqualified in Overall satisfaction with VERITAS Vision System, making N=114
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Rating of overall satisfaction with anterior chamber stability | 0.991 Proportion of Eyes |
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Rating of followability | 0.991 Proportion of Eyes |
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Rating of holdability | 0.991 Proportion of Eyes |
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Rating of Phaco (cutting) efficiency | 1.00 Proportion of Eyes |
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Satisfaction with usability of VERITAS Vision System | 1.00 Proportion of Eyes |
| Veritas Vision System | Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5 | Overall satisfaction with VERITAS Vision System * | 0.991 Proportion of Eyes |