A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Intraocular Lens.

A Clinical Study Comparing Postoperative Outcomes Between the TECNIS Eyhance™ Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DIU and the TECNIS Synergy® Toric II Intraocular Lens With TECNIS Simplicity Delivery System, Model Series DFW to the TECNIS® Toric Intraocular Lens Model Series ZCT

This is a prospective, multi-center, masked, three-arm, randomized clinical study of the TECNIS Eyhance Toric II IOL (test #1) and TECNIS Synergy Toric II (test #2) compared to the TECNIS Toric 1-Piece IOL (control).

Study Overview

• Status: Terminated
• Conditions: Cataract
• Intervention / Treatment: Device: Model DIU; Device: Model DFW; Device: Model ZCT

• Study Type: Interventional
• Enrollment (Actual): 37
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Study Contact; Phone Number: 714-679-8508; Email: LConnol1@its.jnj.com

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 91325
      • Shultz Chang Vision
    • Orange, California, United States, 92868
      • Coastal Vision
    • San Francisco, California, United States, 94115
      • Pacific Eye Associates, A Medical Corporation
  • Hawaii
    • Honolulu, Hawaii, United States, 96817
      • Aloha Vision Consultants
  • Texas
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:

1. Male or female at least 22 years of age
2. Have a cataract in one or both eyes, with planned phacoemulsification and intraocular lens implantation with a toric intraocular lens
3. Regular corneal astigmatism and predicted postoperative residual astigmatism of less than 1.00 D after implantation with a toric intraocular lens in the study eye(s)
4. Availability, willingness and sufficient cognitive awareness to understand the purpose of the examination procedures and comply with postoperative visits
5. Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries.

Exclusion Criteria:

Eligible subjects will be enrolled based on surgeon's determination of meeting the minimum study criteria in one or both eyes:

1. Best-corrected distance visual acuity better than 20/40 Snellen (0.3 logMAR)
2. Potential visual acuity estimated to be worse than 20/32 Snellen (0.2 logMAR)
3. Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, Including prophylactic peripheral iridotomies and peripheral laser retinal repairs
4. Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
5. Pupil abnormalities (non-reactive, fixed pupils, or abnormally shaped pupils) or unable to dilate to visualize IOL axis (approximately 6.0 mm)
6. Inability to achieve keratometric stability for contact lens wearers (as defined in Section 10.3 Preoperative Procedures)
7. Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
8. Use of systemic or ocular medications that may affect vision
9. Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin (e.g., Flomax, Flomaxtra, Rapaflo) 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)
10. Poorly controlled diabetes
11. Acute, chronic, or uncontrolled systemic or ocular disease or illness that, in the opinion of the investigator, would increase the operative risk or confound the outcome(s) of the study (e.g., immunocompromised, connective tissue disease, suspected glaucoma, glaucomatous changes in the fundus or visual field, ocular inflammation, etc.). Note: controlled ocular hypertension without glaucomatous changes (optic nerve cupping and visual field loss) is acceptable.
12. Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
13. Concurrent participation or participation in any other clinical study within 30 days prior to the preoperative visit
14. Any other systemic or ocular disease that, in the opinion of the investigator, may affect the patient's eligibility for the study, affect visual acuity or may require surgical intervention during the study (e.g., macular degeneration, cystoid macular edema, diabetic retinopathy, etc.).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Eyhance Toric II IOL; Model DIU	Device: Model DIU; Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
Experimental: TECNIS Synergy Toric II; Model DFW	Device: Model DFW; Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.
Active Comparator: TECNIS Toric 1-Piece IOL; Model ZCT	Device: Model ZCT; Subjects will be randomized to a treatment group (masked) in ratio 1:1:1. Surgeons will perform standardized, small-incision, cataract surgery and implant the study lenses using a JJSV-validated insertion system qualified for use with the lens to be implanted.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rotational Stability of IOL	The percentage of eyes with rotational stability of the IOL at postoperative 6 months	6-months post-operative

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2022
• Primary Completion (Actual): April 7, 2023
• Study Completion (Actual): April 7, 2023

Study Registration Dates

• First Submitted: May 25, 2022
• First Submitted That Met QC Criteria: May 25, 2022
• First Posted (Actual): May 31, 2022

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: JJSV201EYST

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Devices Companies have an agreement with the Yale Open Data Access (YODA) Project to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes