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

NCT04210232 | Completed Results FDA Device

• 1 other identifier: NXGT-201-TTL2
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 12

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.

Conditions

Cataract; Corneal Astigmatism

Outcome Measures

Primary Outcomes (1)

• Overall Surgeon Satisfaction of the Clinical Outcome of Eye Implanted With the TECNIS Toric II

  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).

  3 months postoperative

Study Arms (1)

TECNIS® TORIC II Intraocular Lens (IOL)

EXPERIMENTAL

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)

Interventions

TECNIS® TORIC II Intraocular Lens (IOL) DEVICE

Surgeons will perform standardized, small-incision, cataract surgery and implant in one or both eyes the study lenses.

TECNIS® TORIC II Intraocular Lens (IOL)

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (12)

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

Chesapeake Eye Care and Laser Center

Annapolis, Maryland, 21401, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Oakland Ophthalmic Surgery, P.C.

Birmingham, Michigan, 48009, United States

Location

Tekwani Vision Center

St Louis, Missouri, 63109, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

Carolina Cataract & Laser Center

Ladson, South Carolina, 29456, United States

Location

Key & Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

Parkhurst NuVision

San Antonio, Texas, 78229, United States

Location

Clarus Eye Center

Lacey, Washington, 98503, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Eugenia K. Thomas
• Organization: Johnson & Johnson Surgical Vision

EThoma39@its.jnj.com

+1 657 2903260

Study Officials

• Johnson & Johnson Surgical Vision Clinical Trials

  Johnson & Johnson Surgical Vision

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2019
• First Posted: December 24, 2019
• Study Start: January 14, 2020
• Primary Completion: September 11, 2020
• Study Completion: September 11, 2020
• Last Updated: October 12, 2021
• Results First Posted: October 12, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will share

Locations

US (12)