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

Clinical Investigation of Rotational Stability of the TECNIS® Toric II Intraocular Lens

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.

Study Overview

• Status: Completed
• Conditions: Cataract; Corneal Astigmatism
• Intervention / Treatment: Device: TECNIS® Toric II

• Study Type: Interventional
• Enrollment (Actual): 125
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye and Laser Center, Inc.
    • Los Angeles, California, United States, 92705
      • University of California
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic
  • North Dakota
    • W. Fargo, North Dakota, United States, 58078
      • Vance Thompson Vision, ND
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • Texas
    • Dallas, Texas, United States, 75243
      • JW Eye Associates, P.A. DBA Key-Whitman Eye Center
    • Hurst, Texas, United States, 76054
      • Texas Eye & Laser Center, P.A.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit	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.	1 week postoperative

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2020
• Primary Completion (Actual): April 6, 2021
• Study Completion (Actual): June 1, 2021

Study Registration Dates

• First Submitted: March 27, 2020
• First Submitted That Met QC Criteria: March 27, 2020
• First Posted (Actual): March 31, 2020

Study Record Updates

• Last Update Posted (Actual): June 1, 2022
• Last Update Submitted That Met QC Criteria: May 5, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract; Astigmatism
• Other Study ID Numbers: NXGT-202-QROS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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

Drug and device information, study documents

• 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