A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL

A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens

This is a multicenter, prospective, randomized, subject- and evaluator-masked, bilateral-implant study conducted at up to 15 sites worldwide. A total of up to 280 subjects will be randomized in a 1:1 ratio for implantation with either the TECNIS Symfony plus IOL Model ZHR00V or the Trifocal IOL. This will ensure that data from at least 100 subjects in the TECNIS Symfony plus lens group and at least 100 subjects in the Trifocal lens group will be available for analysis at the 6-month follow-up timepoint. All subjects will be followed for up to 6 months postoperative.

Study Overview

• Status: Completed
• Conditions: Refractive Error; Cataract
• Intervention / Treatment: Device: TECNIS Symfony plus IOL Model ZHR00V; Device: Trifocal Intraocular lens

• Study Type: Interventional
• Enrollment (Actual): 205
• Phase: Not Applicable

Contacts and Locations

Study Locations

• New Zealand
  • Auckland
    • Remuera, Auckland, New Zealand, 1050
      • Auckland Eye Institute
• Philippines
  • Makati, Philippines, 1200
    • Asian Eye Institute
• Spain
  • Cordoba, Spain
    • Clinica de Oftalmologia de Cordoba
  • Madrid, Spain
    • Centro Ocular de Alta Technologia Oftalmos
  • Madrid, Spain
    • Miranza IOL Madrid

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

(all criteria apply to both eyes):

• Age 22 and older
• Bilateral cataracts or clear crystalline lenses for which posterior chamber IOL implantation has been planned
• Potential postoperative best corrected distance visual acuity (BCDVA) of 0.66 decimal (20/30 or 6/9 Snellen) or better
• Predicted postoperative corneal astigmatism less than 1.0 D, including posterior corneal astigmatism (PCA)
• Clear intraocular media other than cataract in each eye
• Availability, willingness and sufficient cognitive awareness to comply with examination procedures
• Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided
• Written informed consent for participation in the study and data protection.

Exclusion Criteria:

• (including device labeling, all criteria apply to both eyes):

  • Require an intraocular lens power outside the available range of +14.0 to +26.0 D
  • Irregular corneal astigmatism (as evaluated by topography)
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery, including prophylactic peripheral iridotomies and peripheral laser retinal repairs
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies (e.g., any observed guttata) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 or 6/9 Snellen) during the study
  • Inability to achieve keratometric stability for contact lens wearers
  • Recent ocular trauma or ocular surgery that is not resolved/stable or may affect visual outcomes or increase risk to the subject
  • Pupil abnormalities that may affect visual outcomes or increase risk to the subject
  • Subjects with diagnosed degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that are predicted to cause visual acuity loss to a level worse than 0.66 decimal (20/30 or 6/9 Snellen) 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, in the opinion of the investigator, may affect vision
  • Prior, current, or anticipated use during 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 (e.g., poor dilation or a lack of adequate iris structure to perform standard cataract surgery)
  • Poorly-controlled diabetes or hypertension that, in the opinion of the investigator, may mpact visual outcome or increase the risk to the subject
  • 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.

  • Known ocular disease or pathology that, in the opinion of the investigator,

    • may affect visual acuity (e.g., ocular surface conditions)
    • may require surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, uncontrolled glaucoma, etc.)
    • may be expected to require retinal laser treatment or other surgical intervention during the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • Pregnancy, planned pregnancy, presently lactating, or another condition associated with hormonal fluctuation that could lead to refractive changes
  • Concurrent participation or participation within 60 days prior to the 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: Investigational Lens; TECNIS Symfony plus IOL Model ZHR00V	Device: TECNIS Symfony plus IOL Model ZHR00V; IOL replaces the natural lens removed during cataract surgery
Active Comparator: Control Lens; Trifocal Intraocular Lens	Device: Trifocal Intraocular lens; IOL replaces the natural lens removed during cataract surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Binocular distance-corrected VA of 20/25	Percent of subjects who achieve binocular distance-corrected VA of 20/25 (6.7.5) Snellen or better at far, intermediate, and near (40 cm)	3 months
Binocular uncorrected VA of 20/32	Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near (40 cm)	3 months

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): January 24, 2020
• Primary Completion (Actual): July 14, 2021
• Study Completion (Actual): July 14, 2021

Study Registration Dates

• First Submitted: November 6, 2019
• First Submitted That Met QC Criteria: November 6, 2019
• First Posted (Actual): November 7, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract
• Other Study ID Numbers: SUR-IOL-652-3002

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: No