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

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

Tracking Information

• First Submitted Date: December 23, 2019
• First Posted Date: December 24, 2019
• Results First Submitted Date: September 2, 2021
• Results First Posted Date: October 12, 2021
• Last Update Posted Date: October 12, 2021
• Actual Study Start Date: January 14, 2020
• Actual Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 2, 2021)

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).

Original Primary Outcome Measures (submitted: December 23, 2019)

The percentage of eyes with overall surgeon satisfaction being satisfied or very satisfied (defined by a score of 4 or 5) [ Time Frame: 3 months ]

Overall surgeon satisfaction of the clinical outcomes achieved in the implanted eye at the 3-month study visit is assessed based on the question "Please rate your overall level of satisfaction with the clinical outcomes achieved in the implanted eye" in Surgeon Satisfaction Questionnaire (SSQ)

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Post-market Study to Obtain Surgeon Feedback on Clinical Outcome in Eyes Implanted With TECNIS Toric II IOL
• Official Title: Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Cataract
• Corneal Astigmatism

Intervention

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.

Study Arms

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

Intervention: Device: TECNIS® TORIC II Intraocular Lens (IOL)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 2, 2021): 54
• Original Estimated Enrollment (submitted: December 23, 2019): 1100
• Actual Study Completion Date: September 11, 2020
• Actual Primary Completion Date: September 11, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04210232
• Other Study ID Numbers: NXGT-201-TTL2
• Has Data Monitoring Committee: No

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

• 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: Johnson & Johnson Surgical Vision, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Johnson & Johnson Surgical Vision Clinical Trials; Johnson & Johnson Surgical Vision

• PRS Account: Johnson & Johnson Surgical Vision, Inc.
• Verification Date: October 2021