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

• ClinicalTrials.gov Identifier: NCT04210232
• Recruitment Status: Completed
• First Posted: December 24, 2019
• Results First Posted: October 12, 2021
• Last Update Posted: October 12, 2021
• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Information provided by (Responsible Party): Johnson & Johnson Surgical Vision, Inc.

• Study Type: Interventional
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Cataract; Corneal Astigmatism
• Intervention: Device: TECNIS® TORIC II Intraocular Lens (IOL)
• Enrollment: 54

Participant Flow

Recruitment Details
Pre-assignment Details	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.

Arm/Group Title	TECNIS Toric II
Arm/Group Description	Study Lens
Period Title: Overall Study
Started	54
Completed	54
Not Completed	0

Baseline Characteristics

Arm/Group Title		TECNIS Toric II
Arm/Group Description		Study Lens
Overall Number of Baseline Participants		54
Baseline Analysis Population Description		[Not Specified]
Age, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	54 participants
<60 years		3
60-69 years		19
70-79 years		25
>=80 years		7
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	54 participants
	Female	29 53.7%
	Male	25 46.3%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	54 participants
	Hispanic or Latino	2 3.7%
	Not Hispanic or Latino	52 96.3%
	Unknown or Not Reported	0 0.0%
Race/Ethnicity, Customized; Measure Type: Number; Unit of measure: Participants	Number Analyzed	54 participants
Asian		1
African American		2
Native hawaiian/Pacific islander		0
Caucasian		51
Other		0
Not Reported		0

Outcome Measures

1. Primary Outcome

Title	Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II
Description	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).
Time Frame	3 months postoperative

Outcome Measure Data

Analysis Population Description

All Toric II Eyes

Arm/Group Title	TECNIS Toric II
Arm/Group Description:	Study Lens
Overall Number of Participants Analyzed	53
Overall Number of Units Analyzed; Type of Units Analyzed: Eyes	85
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: Percentage of eyes
Very Satisfied/Satisfied	100; (95.8 to 100)
Undecided/Dissatisfied/Very Dissatisfied	0; (0 to 4.2)

Adverse Events

Time Frame	3 months postoperative
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	TECNIS Toric II
Arm/Group Description	Study Lens
All-Cause Mortality
	TECNIS Toric II
	Affected / at Risk (%)
Total	0/54 (0.00%)
Serious Adverse Events
	TECNIS Toric II
	Affected / at Risk (%)	# Events
Total	6/54 (11.11%)
Cardiac disorders
Hospitalization due to heart attack *	2/54 (3.70%)	2
Eye disorders
Cystoid Macular Edema †	1/54 (1.85%)	1
Gastrointestinal disorders
Hospitalization due to bleeding varices *	1/54 (1.85%)	1
Hospitalization due to vomiting of blood *	1/54 (1.85%)	1
Renal and urinary disorders
Hospitalization *	1/54 (1.85%)	1
Respiratory, thoracic and mediastinal disorders
Hospitalization due to pneumonia *	1/54 (1.85%)	1
* Indicates events were collected by non-systematic assessment; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	TECNIS Toric II
	Affected / at Risk (%)	# Events
Total	0/54 (0.00%)

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The sponsor must review results communication prior to public release and can embargo communications regarding trial results at anytime.

Results Point of Contact

• Name/Title: Eugenia K. Thomas
• Organization: Johnson & Johnson Surgical Vision
• Phone: +1 657 2903260
• EMail: EThoma39@its.jnj.com

• Responsible Party: Johnson & Johnson Surgical Vision, Inc.
• ClinicalTrials.gov Identifier: NCT04210232
• Other Study ID Numbers: NXGT-201-TTL2
• First Submitted: December 23, 2019
• First Posted: December 24, 2019
• Results First Submitted: September 2, 2021
• Results First Posted: October 12, 2021
• Last Update Posted: October 12, 2021