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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
Results First Posted : June 1, 2022
Last Update Posted : June 1, 2022
Sponsor:
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

Tracking Information
First Submitted Date  ICMJE March 27, 2020
First Posted Date  ICMJE March 31, 2020
Results First Submitted Date  ICMJE March 30, 2022
Results First Posted Date  ICMJE June 1, 2022
Last Update Posted Date June 1, 2022
Actual Study Start Date  ICMJE June 11, 2020
Actual Primary Completion Date April 6, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2022)
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: March 27, 2020)
Percentage of eyes with ≤ 5º axis misalignment from the intended IOL axis of orientation [ Time Frame: 3 months Postoperative ]
Rotational stability of the IOL will be evaluated by measuring axis misalignment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Rotational Stability of the Tecnis Toric II IOL
Official Title  ICMJE Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Cataract
  • Corneal Astigmatism
Intervention  ICMJE Device: TECNIS® Toric II
Toric Intraocular Lens
Study Arms  ICMJE Experimental: TECNIS® Toric II
Subjects will be implanted in one or both eyes with the study lens
Intervention: Device: TECNIS® Toric II
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2021)
125
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2020)
150
Actual Study Completion Date  ICMJE June 1, 2021
Actual Primary Completion Date April 6, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04327518
Other Study ID Numbers  ICMJE NXGT-202-QROS
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
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
Current Responsible Party Johnson & Johnson Surgical Vision, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Johnson & Johnson Surgical Vision, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Johnson & Johnson Surgical Vision Clinical Trials Johnson & Johnson Surgical Vision
PRS Account Johnson & Johnson Surgical Vision, Inc.
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP