Trial Outcomes & Findings for Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL (NCT NCT04210232)

Last Updated: 2021-10-12

Results Overview

Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).

Recruitment status

COMPLETED

Study phase

Target enrollment

54 participants

Primary outcome timeframe

3 months postoperative

Results posted on

2021-10-12

Participant Flow

87 subjects signed informed consent in the study. 33 were screen failures and 54 subjects were treated/implanted across 8 clinical sites in the US. Of the 54 subjects treated, 32 subjects were treated bilaterally, and 22 subjects were treated unilaterally.

Participant milestones

Participant milestones
Measure	TECNIS Toric II Study Lens
Overall Study STARTED	54
Overall Study COMPLETED	54
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TECNIS Toric II n=54 Participants Study Lens
Age, Customized <60 years	3 Participants n=5 Participants
Age, Customized 60-69 years	19 Participants n=5 Participants
Age, Customized 70-79 years	25 Participants n=5 Participants
Age, Customized >=80 years	7 Participants n=5 Participants
Sex: Female, Male Female	29 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized African American	2 Participants n=5 Participants
Race/Ethnicity, Customized Native hawaiian/Pacific islander	0 Participants n=5 Participants
Race/Ethnicity, Customized Caucasian	51 Participants n=5 Participants
Race/Ethnicity, Customized Other	0 Participants n=5 Participants
Race/Ethnicity, Customized Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months postoperative

Population: All Toric II Eyes

Outcome measures

Outcome measures
Measure	TECNIS Toric II n=85 Eyes Study Lens
Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II Very Satisfied/Satisfied	100 Percentage of eyes Interval 95.8 to 100.0
Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II Undecided/Dissatisfied/Very Dissatisfied	0 Percentage of eyes Interval 0.0 to 4.2

Adverse Events

TECNIS Toric II

Serious events: 6 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	TECNIS Toric II n=54 participants at risk Study Lens
Gastrointestinal disorders Hospitalization due to bleeding varices	1.9% 1/54 • Number of events 1 • 3 months postoperative
Cardiac disorders Hospitalization due to heart attack	3.7% 2/54 • Number of events 2 • 3 months postoperative
Eye disorders Cystoid Macular Edema	1.9% 1/54 • Number of events 1 • 3 months postoperative
Renal and urinary disorders Hospitalization	1.9% 1/54 • Number of events 1 • 3 months postoperative
Gastrointestinal disorders Hospitalization due to vomiting of blood	1.9% 1/54 • Number of events 1 • 3 months postoperative
Respiratory, thoracic and mediastinal disorders Hospitalization due to pneumonia	1.9% 1/54 • Number of events 1 • 3 months postoperative

Other adverse events

Adverse event data not reported

Additional Information

Eugenia K. Thomas

Johnson & Johnson Surgical Vision

Phone: +1 657 2903260

Email: [email protected]

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