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

NCT ID: NCT04210232

Last Updated: 2021-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 54 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-14
• Study Completion Date: 2020-09-11

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

TECNIS® TORIC II Intraocular Lens (IOL)

Intervention Type: DEVICE

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

Interventions

TECNIS® TORIC II Intraocular Lens (IOL)

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

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Surgical Vision Clinical Trials

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision

Locations

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

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

NXGT-201-TTL2

Identifier Type: -

Identifier Source: org_study_id