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Trial Outcomes & Findings for Clinical Evaluation of the Next Generation Phaco System (NCT NCT04332640)

NCT ID: NCT04332640

Last Updated: 2022-06-15

Results Overview

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)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

79 participants

Primary outcome timeframe

1 day postoperative

Results posted on

2022-06-15

Participant Flow

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.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure
Veritas Vision System
Next Generation Phaco System
Overall Study
STARTED
79 115
Overall Study
COMPLETED
79 115
Overall Study
NOT COMPLETED
0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Clinical Evaluation of the Next Generation Phaco System

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Veritas Vision System
n=79 Participants
Next Generation Phaco System
Age, Customized
<30 years
0 Participants
n=5 Participants
Age, Customized
30-39 years
0 Participants
n=5 Participants
Age, Customized
40-49 years
2 Participants
n=5 Participants
Age, Customized
50-59 years
17 Participants
n=5 Participants
Age, Customized
60-69 years
32 Participants
n=5 Participants
Age, Customized
>=70 years
28 Participants
n=5 Participants
Sex: Female, Male
Female
57 Participants
n=5 Participants
Sex: Female, Male
Male
22 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
51 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
28 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Asian
2 Participants
n=5 Participants
Race/Ethnicity, Customized
Black
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
0 Participants
n=5 Participants
Race/Ethnicity, Customized
Caucasian
36 Participants
n=5 Participants
Race/Ethnicity, Customized
Central and South American
41 Participants
n=5 Participants
Race/Ethnicity, Customized
Other race
0 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 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

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)

Outcome measures

Outcome measures
Measure
Veritas Vision System
n=115 Eyes
n/N (Eyes with ratings of 4 or 5/eyes treated)
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Rating of followability
0.991 Proportion of Eyes
Interval 0.95 to 1.0
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
Interval 0.95 to 1.0
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Rating of holdability
0.991 Proportion of Eyes
Interval 0.95 to 1.0
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Rating of Phaco (cutting) efficiency
1.00 Proportion of Eyes
Interval 0.97 to 1.0
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Satisfaction with usability of VERITAS Vision System
1.00 Proportion of Eyes
Interval 0.97 to 1.0
Proportion of Eyes With Surgeon Satisfaction Rating Score of 4 or 5
Overall satisfaction with VERITAS Vision System *
0.991 Proportion of Eyes
Interval 0.95 to 1.0

Adverse Events

Veritas Vision System

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Veritas Vision System
n=79 participants at risk
Next Generation Phaco System
Surgical and medical procedures
Posterior capsule rupture due to surgeon error
1.3%
1/79 • Number of events 1 • 48 days
Analysis population include all 79 participants treated using the VERITAS Vision System. All adverse events (AEs), ocular and non-ocular, were monitored/assessed and planned to be reported for each eye separately.

Other adverse events

Adverse event data not reported

Additional Information

Head of Clinical Science

Johnson & Johnson Surgical Vision

Phone: 7142478200

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