Evaluation of the Rotational Stability of the Tecnis Toric II IOL (STEELE)

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ClinicalTrials.gov Identifier: NCT04327518

Recruitment Status : Completed

First Posted : March 31, 2020

Results First Posted : June 1, 2022

Last Update Posted : June 1, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

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
Enrollment	125

Participant Flow

Recruitment Details
Pre-assignment Details	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.


Arm/Group Title	Tecnis Toric II IOl
Arm/Group Description	Study Lens
Arm/Group Description	Study Lens
Period Title: Overall Study
	Number of participants	Number of units (Eyes)
Started	125	202
Completed	124	200
Not Completed	1	2

Baseline Characteristics

Arm/Group Title		Tecnis Toric II IOL
Arm/Group Description		Study lens
Arm/Group Description		Study lens
Overall Number of Baseline Participants		125
Baseline Analysis Population Description		[Not Specified]
Baseline Analysis Population Description		[Not Specified]
Age, Customized Measure Type: Number Unit of measure: Participants	Number Analyzed	125 participants
<60 years		17
60-69 years		47
70-79 years		53
>+80 years		8
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants
	Female	72 57.6%
	Male	53 42.4%
Ethnicity (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants
	Hispanic or Latino	7 5.6%
	Not Hispanic or Latino	118 94.4%
	Unknown or Not Reported	0 0.0%
Race (NIH/OMB) Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	125 participants
	American Indian or Alaska Native	0 0.0%
	Asian	2 1.6%
	Native Hawaiian or Other Pacific Islander	0 0.0%
	Black or African American	9 7.2%
	White	112 89.6%
	More than one race	2 1.6%
	Unknown or Not Reported	0 0.0%

Outcome Measures

1.Primary Outcome


Title	Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit
Description	Absolute difference between intended IOL axis of orientation (immediat...
Description	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.
Time Frame	1 week postoperative

Outcome Measure Data

Analysis Population Description

All Toric II Eyes with Valid Axis Data


Arm/Group Title	Tecnis Toric II IOL
Arm/Group Description:	Study lens
Arm/Group Description:	Study lens
Overall Number of Participants Analyzed	119
Overall Number of Units Analyzed Type of Units Analyzed: Eyes	191
Measure Type: Number Number (95% Confidence Interval) Unit of Measure: Percentage of Eyes
	99.5 (98.5 to 100)

Adverse Events

Time Frame	3 months
Adverse Event Reporting Description	[Not Specified]

Arm/Group Title	Tecnis Toric II IOL
Arm/Group Description	Study lens
Arm/Group Description	Study lens
All-Cause Mortality
	Tecnis Toric II IOL
	Affected / at Risk (%)
Total	0/125 (0.00%)
Serious Adverse Events Serious Adverse Events
	Tecnis Toric II IOL
	Affected / at Risk (%)	# Events
Total	4/125 (3.20%)
Cardiac disorders
Myocardial Infarction ^*	2/125 (1.60%)	2
Eye disorders
Cystoid Macular Edema ^*	1/125 (0.80%)	1
Hyphema ^*	1/125 (0.80%)	1
Hemorrhagic Choroidal Detachment ^*	1/125 (0.80%)	1
Infections and infestations
COVID-19 ^*	1/125 (0.80%)	1
Respiratory, thoracic and mediastinal disorders
Pulmonary Bilateral embolism ^*	1/125 (0.80%)	1
* Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Tecnis Toric II IOL
	Affected / at Risk (%)	# Events
Total	0/125 (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

Layout table for Results Point of Contact information

Name/Title:	Director of Clinical Science, Ophthalmic Implants
Organization:	Johnson & Johnson Surgical Vision
Phone:	7142478200
EMail:	EThoma39@its.jnj.com

Layout table for additonal information

Responsible Party:	Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:	NCT04327518
Other Study ID Numbers:	NXGT-202-QROS
First Submitted:	March 27, 2020
First Posted:	March 31, 2020
Results First Submitted:	March 30, 2022
Results First Posted:	June 1, 2022
Last Update Posted:	June 1, 2022

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