Evaluation of the Rotational Stability of the Tecnis Toric II IOL

NCT04327518 | Completed Results FDA Device

• 1 other identifier: NXGT-202-QROS
• Study Type: interventional
• Target: 125
• Locations: 1 country
• Sites: 7

Brief Summary

This is a prospective, multicenter, single-arm, open-label clinical study of the commercially available TECNIS Toric II IOL. The study will be conducted in up to 192 subjects needing unilateral or bilateral cataract surgery in up to 8 sites in United States (US). The subjects will be followed for up to 3-months postoperatively.

Conditions

Cataract; Corneal Astigmatism

Outcome Measures

Primary Outcomes (1)

• Percentage of Eyes With ≤ 5º Lens Axis Misalignment From the Intended IOL Axis of Orientation at the 1-week Postoperative Visit

  Absolute difference between intended IOL axis of orientation (immediately at the end of surgery) and follow-up visit(s) were measured by a photographic based method.

  1 week postoperative

Study Arms (1)

TECNIS® Toric II

EXPERIMENTAL

Subjects will be implanted in one or both eyes with the study lens

Device: TECNIS® Toric II

Interventions

TECNIS® Toric II DEVICE

Toric Intraocular Lens

TECNIS® Toric II

Eligibility Criteria

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

You may qualify if:

• Minimum 22 years of age;
• Unilateral or Bilateral cataracts for which cataract extraction and posterior chamber IOL implantation have been planned;
• Pre-existing corneal astigmatism of one diopter or greater;
• Predicted residual refractive cylinder based on toric IOL calculator, considering surgically induced astigmatism (SIA) and posterior corneal astigmatism (PCA) must be ≤0.50 D;
• Potential for postoperative BCDVA of 20/30 Snellen or better;
• Clear intraocular media other than cataract in each eye;
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures and study visits;
• Signed informed consent form (ICF) and health insurance portability and accountability act (HIPAA) authorization;
• Ability to understand and respond to a questionnaire in English.

You may not qualify if:

• Irregular corneal astigmatism;
• Any corneal pathology/abnormality other than regular corneal astigmatism or corneal instability due to contact lens wear;
• Previous corneal or intraocular surgery;
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.);
• Any pupil abnormalities (non-reactive, fixed, or abnormally shaped pupils);
• Dilated pupil size of \< 6.0 mm;
• Recurrent severe anterior or posterior segment inflammation or uveitis;
• 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 or systemic disease that, in the opinion of the investigator, may affect visual acuity or require surgical intervention during the course of the study, \[macular degeneration, cystoid macular edema, proliferative diabetic retinopathy (severe), uncontrolled glaucoma, irregular corneal astigmatism, choroidal hemorrhage, concomitant severe eye disease, extremely shallow anterior chamber, microphthalmos, non-age related cataract, severe corneal dystrophy, severe optic nerve atrophy, etc.\];
• Use of systemic or ocular medications (e.g., Flomax) that may affect vision including prior, current, or anticipated use during the course of the study that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery);
• Patient is pregnant, plans to become pregnant, is lactating or has another condition associated with the fluctuation of hormones that could lead to refractive changes;
• Concurrent participation or participation within 30 days prior to the preoperative visit in any other clinical study.
• Planned monovision correction (eye designated for near correction)

Sponsors & Collaborators

• Johnson & Johnson Surgical Vision, Inc.: lead

Study Sites (7)

Empire Eye and Laser Center, Inc.

Bakersfield, California, 93309, United States

Location

University of California

Los Angeles, California, 92705, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

Vance Thompson Vision, ND

West Fargo, North Dakota, 58078, United States

Location

Cincinnati Eye Institute

Cincinnati, Ohio, 45242, United States

Location

JW Eye Associates, P.A. DBA Key-Whitman Eye Center

Dallas, Texas, 75243, United States

Location

Texas Eye & Laser Center, P.A.

Hurst, Texas, 76054, United States

Location

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Director of Clinical Science, Ophthalmic Implants
• Organization: Johnson & Johnson Surgical Vision

EThoma39@its.jnj.com

7142478200

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: March 27, 2020
• First Posted: March 31, 2020
• Study Start: June 11, 2020
• Primary Completion: April 6, 2021
• Study Completion: June 1, 2021
• Last Updated: June 1, 2022
• Results First Posted: June 1, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will share

Locations

US (7)