Evaluation of the Rotational Stability of the Tecnis Toric II IOL (STEELE)
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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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract Corneal Astigmatism | Device: TECNIS® Toric II | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: TECNIS® Toric II
Subjects will be implanted in one or both eyes with the study lens
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Device: TECNIS® Toric II
Toric Intraocular Lens |
- 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.

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Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Minimum 22 years of age;
- Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;
- Pre-existing corneal astigmatism of one diopter or greater;
- Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;
- Potential for postoperative BCDVA of 20/30 Snellen or better;
- Clear intraocular media other than cataract in each eye;
- Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;
- Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;
- Ability to understand and respond to a questionnaire in English.
Exclusion Criteria:
- Irregular corneal astigmatism;
- Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;
- Previous corneal or intraocular surgery;
- Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
- Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);
- Dilated pupil size of < 6.0 mm;
- Recurrent severe anterior or posterior segment inflammation or uveitis;
- 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;
- 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.];
- 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);
- 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;
- Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
- Planned monovision correction (eye designated for near correction)

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
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 |
Study Director: | Johnson & Johnson Surgical Vision Clinical Trials | Johnson & Johnson Surgical Vision |
Documents provided by Johnson & Johnson Surgical Vision, Inc.:
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 |
Results First Posted: | June 1, 2022 |
Last Update Posted: | June 1, 2022 |
Last Verified: | May 2022 |
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 |
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 |
Cataract Astigmatism Lens Diseases Eye Diseases Refractive Errors |