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Trial record 1 of 1 for:    Johnson & Johnson [Lead] | Steele
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Evaluation of the Rotational Stability of the Tecnis Toric II IOL (STEELE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04327518
Recruitment Status : Completed
First Posted : March 31, 2020
Last Update Posted : June 21, 2021
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

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
Cataract Corneal Astigmatism Device: TECNIS® Toric II Not Applicable

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Study Type : Interventional  (Clinical Trial)
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 : June 11, 2020
Actual Primary Completion Date : April 6, 2021
Actual Study Completion Date : June 1, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

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




Primary Outcome Measures :
  1. Percentage of eyes with ≤ 5º axis misalignment from the intended IOL axis of orientation [ Time Frame: 1 week Postoperative ]
    Rotational stability of the IOL will be evaluated by measuring axis misalignment



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04327518


Locations
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United States, California
Empire Eye and Laser Center, Inc.
Bakersfield, California, United States, 93309
University of California
Los Angeles, California, United States, 92705
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, North Dakota
Vance Thompson Vision, ND
W. Fargo, North Dakota, United States, 58078
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, Texas
JW Eye Associates, P.A. DBA Key-Whitman Eye Center
Dallas, Texas, United States, 75243
Texas Eye & Laser Center, P.A.
Hurst, Texas, United States, 76054
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
Investigators
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Study Director: Johnson & Johnson Surgical Vision Clinical Trials Johnson & Johnson Surgical Vision
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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT04327518    
Other Study ID Numbers: NXGT-202-QROS
First Posted: March 31, 2020    Key Record Dates
Last Update Posted: June 21, 2021
Last Verified: June 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu
URL: http://yoda.yale.edu

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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:
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Cataract
Astigmatism
Lens Diseases
Eye Diseases
Refractive Errors