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

Completed · Not applicable

Conditions studied: Cataract, Corneal Astigmatism

In brief

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.

Key facts

Study ID

NCT04210232

Run by

Johnson & Johnson Surgical Vision, Inc.

People needed

54

Starts

2020-01-14

Expected to finish

2020-09-11

Last updated by the study team

2021-10-12

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• Empire Eye & Laser Center — Bakersfield, California, United States
• Jones Eye Clinic — Sioux City, Iowa, United States
• Chesapeake Eye Care and Laser Center — Annapolis, Maryland, United States
• Eye Doctors of Washington — Chevy Chase, Maryland, United States
• Oakland Ophthalmic Surgery, P.C. — Birmingham, Michigan, United States
• Tekwani Vision Center — St Louis, Missouri, United States
• Cincinnati Eye Institute — Cincinnati, Ohio, United States
• Carolina Cataract & Laser Center — Ladson, South Carolina, United States
• Key & Whitman Eye Center — Dallas, Texas, United States
• Texas Eye and Laser Center — Hurst, Texas, United States
• Parkhurst NuVision — San Antonio, Texas, United States
• Clarus Eye Center — Lacey, Washington, United States

Full record on ClinicalTrials.gov

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