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

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

Post-market Evaluation of Surgeon Feedback on TECNIS® TORIC II Intraocular Lens (IOL)

NCT04210232•Johnson & Johnson Surgical Vision, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

22 - No limit years

Sex

ALL

Healthy Volunteers

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.

Locations (12)

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

Key Dates

Start Date

January 14, 2020

Primary Completion Date

September 11, 2020

Completion Date

September 11, 2020

Last Updated

October 12, 2021

Enrollment

ACTUAL participants

Conditions

CataractCorneal Astigmatism

Interventions

TECNIS® TORIC II Intraocular Lens (IOL)

DEVICE

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

NCT06979752

Glaucoma, Open Angle, Pseudo-exfoliativeCataract

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RECRUITING

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

NCT07362043

Cataract Surgery

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 12, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Efficacy and Safety of Tran Cannula in Combined Pseudoexfoliative Glaucoma and Cataract Surgery Compared With Augmented Ocular Irrigation

Assessment of a Hand-held Femtosecond Laser to Perform Anterior Capsulorhexis During Cataract Surgery (Post-market Study)

IC-8 Apthera IOL New Enrollment Post Approval Study

HUD Surgical Guidance for Toric Alignment

PRO-232 in Patients Subjected to Cataract Surgery

Outcomes of Clareon PanOptix Pro in Patients With Prior Myopic Refractive Surgery