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

Primary Purpose

Cataract, Refractive Error

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
TECNIS Symfony plus IOL Model ZHR00V
Trifocal Intraocular lens
Sponsored by
Johnson & Johnson Surgical Vision, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Auckland Eye Institute
  • Asian Eye Institute
  • Clinica de Oftalmologia de Cordoba
  • Centro Ocular de Alta Technologia Oftalmos
  • Miranza IOL Madrid

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Investigational Lens

Control Lens

Arm Description

TECNIS Symfony plus IOL Model ZHR00V

Trifocal Intraocular Lens

Outcomes

Primary Outcome Measures

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)
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)

Secondary Outcome Measures

Full Information

First Posted
November 6, 2019
Last Updated
August 4, 2021
Sponsor
Johnson & Johnson Surgical Vision, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04156737
Brief Title
A Comparative Study of TECNIS Symfony Plus IOL and a Trifocal IOL
Official Title
A Comparative Clinical Evaluation of a New TECNIS® Presbyopia-correcting Intraocular Lens Against a Trifocal Intraocular Lens
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2020 (Actual)
Primary Completion Date
July 14, 2021 (Actual)
Study Completion Date
July 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johnson & Johnson Surgical Vision, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract, Refractive Error

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Unmasked study personnel at the site will be trained to the randomization process through the EDC system and will randomize subjects. The surgeon and the operative staff will know which lens type is implanted. There may also be site coordinators and other site study staff, such as those performing slit-lamp exams, who will be unmasked. Unmasked study site staff will be instructed not to disclose the lens type the subject received or to talk about the lens to any masked evaluators or to the study subjects. The subjects and the study technicians performing the postoperative vision tests are to be masked through study completion. To maintain subject masking, a temporary IOL implant identification card will be issued to the subject at the time of surgery. Following completion of the final study exam, each subject will be given the permanent IOL implant identification card.
Allocation
Randomized
Enrollment
205 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Investigational Lens
Arm Type
Experimental
Arm Description
TECNIS Symfony plus IOL Model ZHR00V
Arm Title
Control Lens
Arm Type
Active Comparator
Arm Description
Trifocal Intraocular Lens
Intervention Type
Device
Intervention Name(s)
TECNIS Symfony plus IOL Model ZHR00V
Intervention Description
IOL replaces the natural lens removed during cataract surgery
Intervention Type
Device
Intervention Name(s)
Trifocal Intraocular lens
Intervention Description
IOL replaces the natural lens removed during cataract surgery
Primary Outcome Measure Information:
Title
Binocular distance-corrected VA of 20/25
Description
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)
Time Frame
3 months
Title
Binocular uncorrected VA of 20/32
Description
Percent of subjects who achieve binocular uncorrected VA of 20/32 or better at far and near (40 cm)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Johnson & Johnson Surgical Vision Clinical Trials
Organizational Affiliation
Johnson & Johnson Surgical Vision
Official's Role
Study Director
Facility Information:
Facility Name
Auckland Eye Institute
City
Remuera
State/Province
Auckland
ZIP/Postal Code
1050
Country
New Zealand
Facility Name
Asian Eye Institute
City
Makati
ZIP/Postal Code
1200
Country
Philippines
Facility Name
Clinica de Oftalmologia de Cordoba
City
Cordoba
Country
Spain
Facility Name
Centro Ocular de Alta Technologia Oftalmos
City
Madrid
Country
Spain
Facility Name
Miranza IOL Madrid
City
Madrid
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing URL
http://yoda.yale.edu/

Learn more about this trial

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

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