Vision Performance Evaluation of TECNIS EYHANCE™ With TECNIS SIMPLICITY™ Compared to TECNIS® 1-piece Intraocular Lenses

Clinical Evaluation of the Vision Performance of TECNIS EYHANCE™ Intraocular Lenses With TECNIS SIMPLICITY™ as Compared to TECNIS® 1-piece Intraocular Lenses

This study is a 6-month, prospective, multicenter, bilateral, randomized subject- and evaluator-masked, clinical investigation of the TECNIS Eyhance IOL versus the TECNIS 1-piece IOL.

The study will be conducted at up to 15 sites in the U.S.A and will enroll approximately 220 subjects to achieve approximately 200 randomized and bilaterally implanted subjects, resulting in approximately 100 evaluable subjects in each lens group at 6 months. Subjects are to be implanted with the same IOL in both eyes: TECNIS Eyhance IOL or the TECNIS 1-Piece IOL. The eye implanted first will be considered the primary study eye.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: Tecnis Eyhance; Device: Tecnis 1 piece IOL

• Study Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
    • Long Beach, California, United States, 90805
      • Southern California Eye Physicians and Associates
  • Florida
    • Sarasota, Florida, United States, 34239
      • Center for Sight
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Chesapeake Eye Care & Laser Center
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Tekwani Vision Center
  • Pennsylvania
    • Cranberry Township, Pennsylvania, United States, 16606
      • Scott & Christie and Associates, PC
    • Kingston, Pennsylvania, United States, 18704
      • Eye Care Specialists
  • Texas
    • Dallas, Texas, United States, 75243
      • Key-Whitman Eye Center
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Houston, Texas, United States, 77027
      • Berkeley Eye Institute, P.A.
    • Hurst, Texas, United States, 76054
      • Texas Eye and Laser Center
    • San Antonio, Texas, United States, 78229
      • Parkhurst NuVision
    • San Antonio, Texas, United States, 78209
      • Focal Point Vision
    • San Antonio, Texas, United States, 78229
      • R & R Eye Research, LLC

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Minimum 22 years of age
• Bilateral cataracts for which posterior chamber IOL implantation has been planned
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
• Potential for postoperative best corrected visual acuity of 20/30 Snellen or better

• Corneal astigmatism parameters:

  • Normal corneal topography and no irregular corneal astigmatism
  • Postoperative astigmatism can be surgically managed to be less than 1 D in each eye
• Clear intraocular media other than cataract in each eye
• Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures and study visits
• Signed informed consent and HIPAA authorization or equivalent documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries
• Ability to understand and respond to a questionnaire in English

Exclusion Criteria:

• Any conditions or circumstances, including those specified in the TECNIS Eyhance™ IOL Directions for Use, that, in the opinion of the investigator, may increase risk over benefit or result in an adverse event during the study.
• Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
• Concurrent participation or participation within 60 days prior to preoperative visit in any other clinical trial
• Desire for monovision correction

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study Lens; Tecnis Eyhance	Device: Tecnis Eyhance; Investigational intraocular lens replaces the natural lens removed during cataract surgery in both eyes.
Active Comparator: Control Lens; Tecnis 1 piece IOL (Intraocular lens)	Device: Tecnis 1 piece IOL; Control intraocular lens replaces the natural lens removed during cataract surgery in both eyes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MONOCULAR BEST-CORRECTED DISTANCE VISUAL ACUITY (BCDVA)	the mean monocular difference in Best-Corrected Distance Visual Acuity for the first eye between lens groups	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MONOCULAR DISTANCE-CORRECTED INTERMEDIATE VISUAL ACUITY AT 66 CM (DCVA66)	the mean monocular difference in Distance-Corrected Intermediate Visual Acuity at 66cm for first eyes between lens groups	6 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 2, 2021
• Primary Completion (Actual): June 17, 2022
• Study Completion (Actual): June 17, 2022

Study Registration Dates

• First Submitted: August 26, 2021
• First Submitted That Met QC Criteria: August 26, 2021
• First Posted (Actual): August 27, 2021

Study Record Updates

• Last Update Posted (Actual): August 28, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EMON-101-EHCE

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.: No