Clinical Investigation of a New Intraocular Lens

Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00

The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.

Study Overview

• Status: Completed
• Conditions: Cataract
• Intervention / Treatment: Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; Device: TECNIS Monofocal IOL, Model ZCB00

• Study Type: Interventional
• Enrollment (Actual): 324
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Rogers, Arkansas, United States, 72756
      • Boozman-Hof Regional Eye Clinic
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye & Laser Center
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Katzen Eye Care & Laser Center
    • Cape Coral, Florida, United States, 33904
      • Cape Coral Eye Center
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Virdi Eye Clinic & Laser Vision Center
  • Indiana
    • Indianapolis, Indiana, United States, 46256
      • Eye Surgeons of Indiana
  • Iowa
    • Sioux City, Iowa, United States, 51104
      • Jones Eye Clinic
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • Eye Doctors of Washington
  • New York
    • Rockville Center, New York, United States, 11570
      • Ophthalmic Consultants of Long Island
  • Pennsylvania
    • Allenwood, Pennsylvania, United States, 17810
      • The Eye Center of Central PA
    • Cranberry Township, Pennsylvania, United States, 16066
      • Scott & Christie and Associates, PC
  • Tennessee
    • Goodlettsville, Tennessee, United States, 37072
      • Loden Vision Center
  • Texas
    • Houston, Texas, United States, 77055
      • Whitsett Vision Group
    • Hurst, Texas, United States, 76054
      • Texas Eye and Laser Center
    • Nacogdoches, Texas, United States, 75965
      • Lehmann Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Minimum 22 years of age
• Bilateral cataracts for which phacoemulsification extraction and posterior IOL implantation have been planned for both eyes
• Preoperative best corrected distance visual acuity (BCDVA) of 20/40 Snellen or worse with or without a glare source
• Potential for postoperative BCDVA of 20/30 Snellen or better
• Corneal astigmatism
• Clear intraocular media, other than cataract
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Signed informed consent and HIPAA authorization
• Ability to understand and respond to a questionnaire in English or Spanish

Exclusion Criteria:

• Requiring an intraocular lens power outside the available range of +16.0 D to +28.0 D
• Pupil abnormalities
• Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
• Prior corneal refractive or intraocular surgery
• Corneal abnormalities
• Inability to achieve keratometric stability for contact lens wearers
• Subjects with diagnosed degenerative visual disorders that are predicted to cause visual acuity losses to a level of 20/30 Snellen or worse during the study
• Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration or tilt, such as pseudoexfoliation, trauma, or posterior capsule defects
• Use of systemic or ocular medications that may affect vision
• Prior, current, or anticipated use during the course of the 6-month study of tamsulosin or silodosin, that may, in the opinion of the investigator, confound the outcome or increase the risk to the subject
• Inability to focus or fixate for prolonged periods of time
• Poorly-controlled diabetes
• 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.
• May be expected to require retinal laser treatment or other surgical intervention during the course of the study
• 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 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: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00; Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00	Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Active Comparator: TECNIS Monofocal IOL, Model ZCB00; Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00	Device: TECNIS Monofocal IOL, Model ZCB00

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Distance Corrected Intermediate Visual Acuity	FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.	At 6 months
Uncorrected Intermediate Visual Acuity	Uncorrected Intermediate Visual Acuity at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Abbott Medical Optics

Publications and helpful links

General Publications

• Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747.

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): June 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 28, 2014
• First Posted (Estimate): July 30, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2017
• Last Update Submitted That Met QC Criteria: November 15, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: EROV-106-ZXRC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No