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Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL

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: NCT04210232
Recruitment Status : Completed
First Posted : December 24, 2019
Results First Posted : October 12, 2021
Last Update Posted : October 12, 2021
Information provided by (Responsible Party):
Johnson & Johnson Surgical Vision, Inc.

Brief Summary:
This is a multicenter, prospective, single-arm, open-label, clinical study of the commercially available TECNIS Toric II, Model ZCU IOL. The study will be conducted in up to 1100 subjects enrolled with 1,000 subjects needing unilateral or bilateral cataract surgery across up to 50 US study sites.

Condition or disease Intervention/treatment Phase
Cataract Corneal Astigmatism Device: TECNIS® TORIC II Intraocular Lens (IOL) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
Actual Study Start Date : January 14, 2020
Actual Primary Completion Date : September 11, 2020
Actual Study Completion Date : September 11, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arm Intervention/treatment
Experimental: TECNIS® TORIC II Intraocular Lens (IOL)
Subjects will be implanted with the TECNIS Toric II IOL in one or both eyes qualified for study inclusion
Device: TECNIS® TORIC II Intraocular Lens (IOL)
Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.

Primary Outcome Measures :
  1. Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II [ Time Frame: 3 months postoperative ]
    Percent of Eyes Rated Very Satisfied or Satisfied with Clinical Outcomes. This endpoint was assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in the Surgeon Satisfaction Questionnaire (SSQ).

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

Inclusion Criteria:

  1. Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
  2. Preoperative corneal astigmatism of one diopter or more in the operative eye;
  3. Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
  4. Clear intraocular media other than cataract in each eye;
  5. Ability to understand, read and write English in order to consent to study participation;
  6. Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
  7. Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.

Exclusion Criteria:

  1. Recurrent severe anterior or posterior segment inflammation or uveitis;
  2. Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
  3. Circumstances that would result in damage to the endothelium during implantation;
  4. Suspected ocular microbial infection;
  5. 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;
  6. Known ocular disease or pathology 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.];
  7. Planned monovision correction;
  8. Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

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): NCT04210232

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United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, Maryland
Chesapeake Eye Care and Laser Center
Annapolis, Maryland, United States, 21401
Eye Doctors of Washington
Chevy Chase, Maryland, United States, 20815
United States, Michigan
Oakland Ophthalmic Surgery, P.C.
Birmingham, Michigan, United States, 48009
United States, Missouri
Tekwani Vision Center
Saint Louis, Missouri, United States, 63109
United States, Ohio
Cincinnati Eye Institute
Cincinnati, Ohio, United States, 45242
United States, South Carolina
Carolina Cataract & Laser Center
Ladson, South Carolina, United States, 29456
United States, Texas
Key & Whitman Eye Center
Dallas, Texas, United States, 75243
Texas Eye and Laser Center
Hurst, Texas, United States, 76054
Parkhurst NuVision
San Antonio, Texas, United States, 78229
United States, Washington
Clarus Eye Center
Lacey, Washington, United States, 98503
Sponsors and Collaborators
Johnson & Johnson Surgical Vision, Inc.
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Study Director: Johnson & Johnson Surgical Vision Clinical Trials Johnson & Johnson Surgical Vision
  Study Documents (Full-Text)

Documents provided by Johnson & Johnson Surgical Vision, Inc.:
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Responsible Party: Johnson & Johnson Surgical Vision, Inc.
ClinicalTrials.gov Identifier: NCT04210232    
Other Study ID Numbers: NXGT-201-TTL2
First Posted: December 24, 2019    Key Record Dates
Results First Posted: October 12, 2021
Last Update Posted: October 12, 2021
Last Verified: October 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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Lens Diseases
Eye Diseases
Refractive Errors