Trial Outcomes & Findings for Evaluation of the Rotational Stability of the Tecnis Toric II IOL (NCT NCT04327518)

Last Updated: 2022-06-01

Results Overview

Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.

Recruitment status

COMPLETED

Study phase

Target enrollment

125 participants

Primary outcome timeframe

1 week postoperative

Results posted on

2022-06-01

Participant Flow

A total of 125 subjects were enrolled. A total of 202 eyes were implanted with the TECNIS Toric II IOL in at least one eye: 80 subjects were treated bilaterally (77 subjects with study lens on both eyes, 3 subjects with non-study lens on first eye and study lens on second eye) and 45 subjects were treated unilaterally. All implanted subjects were examined through 3-months postoperatively.

Unit of analysis: Eyes

Participant milestones

Participant milestones
Measure	Tecnis Toric II IOl Study Lens
Overall Study STARTED	125 202
Overall Study COMPLETED	124 200
Overall Study NOT COMPLETED	1 2

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Evaluation of the Rotational Stability of the Tecnis Toric II IOL

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tecnis Toric II IOL n=125 Participants Study lens
Age, Customized <60 years	17 Participants n=5 Participants
Age, Customized 60-69 years	47 Participants n=5 Participants
Age, Customized 70-79 years	53 Participants n=5 Participants
Age, Customized >+80 years	8 Participants n=5 Participants
Sex: Female, Male Female	72 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	118 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	9 Participants n=5 Participants
Race (NIH/OMB) White	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week postoperative

Population: All Toric II Eyes with Valid Axis Data

Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.

Outcome measures

Outcome measures
Measure	Tecnis Toric II IOL n=191 Eyes Study lens
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit	99.5 Percentage of Eyes Interval 98.5 to 100.0

Adverse Events

Tecnis Toric II IOL

Serious events: 4 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Tecnis Toric II IOL n=125 participants at risk Study lens
Cardiac disorders Myocardial Infarction	1.6% 2/125 • Number of events 2 • 3 months
Infections and infestations COVID-19	0.80% 1/125 • Number of events 1 • 3 months
Eye disorders Cystoid Macular Edema	0.80% 1/125 • Number of events 1 • 3 months
Respiratory, thoracic and mediastinal disorders Pulmonary Bilateral embolism	0.80% 1/125 • Number of events 1 • 3 months
Eye disorders Hyphema	0.80% 1/125 • Number of events 1 • 3 months
Eye disorders Hemorrhagic Choroidal Detachment	0.80% 1/125 • Number of events 1 • 3 months

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Science, Ophthalmic Implants

Johnson & Johnson Surgical Vision

Phone: 7142478200

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