Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
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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: NCT04210232 |
Recruitment Status :
Completed
First Posted : December 24, 2019
Results First Posted : October 12, 2021
Last Update Posted : October 12, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Cataract Corneal Astigmatism | Device: TECNIS® TORIC II Intraocular Lens (IOL) | Not Applicable |
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 |
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
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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. |
- 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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 22 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Unilateral or bilateral cataracts for which phacoemulsification extraction and posterior chamber IOL implantation have been planned;
- Preoperative corneal astigmatism of one diopter or more in the operative eye;
- Potential for postoperative best corrected distance visual acuity (BCDVA) of 20/30 Snellen or better;
- Clear intraocular media other than cataract in each eye;
- Ability to understand, read and write English in order to consent to study participation;
- Availability, willingness, sufficient cognitive awareness to comply with examination procedures;
- Signed Informed Consent Document (ICD) and Health Insurance Portability and Accountability Act (HIPAA) authorization.
Exclusion Criteria:
- Recurrent severe anterior or posterior segment inflammation or uveitis;
- Compromised eye due to previous trauma or developmental defects in which appropriate support of the IOL is not possible;
- Circumstances that would result in damage to the endothelium during implantation;
- Suspected ocular microbial infection;
- 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 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.];
- Planned monovision correction;
- Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.

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
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 |
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: | 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 |
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 |