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STEELE: Evaluation of the Rotational Stability of the Tecnis Toric II IOL

Sponsor
Johnson & Johnson Surgical Vision, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT04327518
Collaborator
(none)
125
Enrollment
7
Locations
1
Arm
11.7
Actual Duration (Months)
17.9
Patients Per Site
1.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.

Condition or Disease Intervention/Treatment Phase
  • Device: TECNIS® Toric II
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
125 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
Actual Study Start Date :
Jun 11, 2020
Actual Primary Completion Date :
Apr 6, 2021
Actual Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: TECNIS® Toric II

Subjects will be implanted in one or both eyes with the study lens

Device: TECNIS® Toric II
Toric Intraocular Lens

Outcome Measures

Primary Outcome Measures

  1. Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit [1 week postoperative]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
22 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Minimum 22 years of age;

  2. Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;

  3. Pre-existing corneal astigmatism of one diopter or greater;

  4. Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;

  5. Potential for postoperative BCDVA of 20/30 Snellen or better;

  6. Clear intraocular media other than cataract in each eye;

  7. Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;

  8. Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;

  9. Ability to understand and respond to a questionnaire in English.

Exclusion Criteria:

  1. Irregular corneal astigmatism;

  2. Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;

  3. Previous corneal or intraocular surgery;

  4. Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);

  5. Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);

  6. Dilated pupil size of < 6.0 mm;

  7. Recurrent severe anterior or posterior segment inflammation or uveitis;

  8. Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects;

  9. Known ocular or systemic disease that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, [macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.];

  10. Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);

  11. Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes;

  12. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

  13. Planned monovision correction (eye designated for near correction)

Contacts and Locations

Locations

Site City State Country Postal Code
1 Empire Eye and Laser Center, Inc. Bakersfield California United States 93309
2 University of California Los Angeles California United States 92705
3 Jones Eye Clinic Sioux City Iowa United States 51104
4 Vance Thompson Vision, ND W. Fargo North Dakota United States 58078
5 Cincinnati Eye Institute Cincinnati Ohio United States 45242
6 JW Eye Associates, P.A. DBA Key-Whitman Eye Center Dallas Texas United States 75243
7 Texas Eye & Laser Center, P.A. Hurst Texas United States 76054

Sponsors and Collaborators

  • Johnson & Johnson Surgical Vision, Inc.

Investigators

  • Study Director: Johnson & Johnson Surgical Vision Clinical Trials, Johnson & Johnson Surgical Vision

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04327518
Other Study ID Numbers:
  • NXGT-202-QROS
First Posted:
Mar 31, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Cataract
Astigmatism

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail 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
Period Title: Overall Study
STARTED 125
COMPLETED 124
NOT COMPLETED 1

Baseline Characteristics

Arm/Group Title Tecnis Toric II IOL
Arm/Group Description Study lens
Overall Participants 125
Age, Customized (Number) [Number]
<60 years
17
13.6%
60-69 years
47
37.6%
70-79 years
53
42.4%
>+80 years
8
6.4%
Sex: Female, Male (Count of Participants)
Female
72
57.6%
Male
53
42.4%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
7
5.6%
Not Hispanic or Latino
118
94.4%
Unknown or Not Reported
0
0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
0
0%
Asian
2
1.6%
Native Hawaiian or Other Pacific Islander
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%

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 (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
Measure Participants 119
Measure Eyes 191
Number (95% Confidence Interval) [Percentage of Eyes]
99.5

Adverse Events

Time Frame 3 months
Adverse Event Reporting Description
Arm/Group Title Tecnis Toric II IOL
Arm/Group Description Study lens
All Cause Mortality
Tecnis Toric II IOL
Affected / at Risk (%) # Events
Total 0/125 (0%)
Serious Adverse Events
Tecnis Toric II IOL
Affected / at Risk (%) # Events
Total 4/125 (3.2%)
Cardiac disorders
Myocardial Infarction 2/125 (1.6%) 2
Eye disorders
Cystoid Macular Edema 1/125 (0.8%) 1
Hyphema 1/125 (0.8%) 1
Hemorrhagic Choroidal Detachment 1/125 (0.8%) 1
Infections and infestations
COVID-19 1/125 (0.8%) 1
Respiratory, thoracic and mediastinal disorders
Pulmonary Bilateral embolism 1/125 (0.8%) 1
Other (Not Including Serious) Adverse Events
Tecnis Toric II IOL
Affected / at Risk (%) # Events
Total 0/125 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

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 Director of Clinical Science, Ophthalmic Implants
Organization Johnson & Johnson Surgical Vision
Phone 7142478200
Email EThoma39@its.jnj.com
Responsible Party:
Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier:
NCT04327518
Other Study ID Numbers:
  • NXGT-202-QROS
First Posted:
Mar 31, 2020
Last Update Posted:
Jun 1, 2022
Last Verified:
May 1, 2022