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Clinical Investigation of the Next-Generation Intraocular Lenses

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03372434
Recruitment Status : Completed
First Posted : December 13, 2017
Results First Posted : July 27, 2021
Last Update Posted : July 27, 2021
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Study Description
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Brief Summary:

This study is a 6-month, prospective, multicenter, subject/evaluator-masked, bilateral, randomized clinical investigation of the TECNIS Next-Generation Model ZFR00 and Model ZYR00 IOLs versus the TECNIS Multifocal Model ZLB00 control IOL.

The study will be conducted at up to 14 sites in the U.S.A and will enroll up to 260 subjects to achieve approximately 220 randomized and bilaterally-implanted subjects, resulting in approximately 195 evaluable subjects (65 in each test group and 65 in the control group) at 1 and 6 months. Subjects are to be implanted with the same IOL in both eyes, the ZFR00 IOL, the ZYR00 IOL or the ZLB00 control IOL. The eye implanted first will be considered the primary study eye.


Condition or disease Intervention/treatment Phase
Cataract Device: Investigational Intraocular Lens Device #1: Model ZFR00 Device: Investigational Intraocular Lens Device #1: Model ZYR00 Device: TECNIS Multifocal Intraocular Lens: Model ZLB00 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 225 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
Actual Study Start Date : January 16, 2018
Actual Primary Completion Date : July 11, 2018
Actual Study Completion Date : October 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cataract

Arms and Interventions
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Arm Intervention/treatment
Experimental: Investigational Lens Device #1
Investigational Intraocular Lens Device #1: Model ZFR00
 Device: Investigational Intraocular Lens Device #1: Model ZFR00
IOL replaces the natural lens removed during cataract surgery.
Experimental: Investigational Lens Device #2
Investigational Intraocular Lens Device #1: Model ZYR00
 Device: Investigational Intraocular Lens Device #1: Model ZYR00
IOL replaces the natural lens removed during cataract surgery.
Active Comparator: Control Device
Control TECNIS Multifocal Intraocular Lens Model ZLB00
 Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
IOL replaces the natural lens removed during cataract surgery.


Outcome Measures
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Primary Outcome Measures :
  1. Distance Corrected Intermediate Visual Acuity [ Time Frame: 1 month ]
    Visual Acuity (VA) was assessed monocularly (each eye separately) under photopic (well-lit) conditions using best distance correction (distance refraction) and high contrast, Early Treatment Diabetic Retinopathy Study (ETDRS) chart at 66 cm from spectacle plane. It was measured in logarithm of the minimum angle of resolution (logMAR), on an ETDRS chart. A lower numeric value represented better VA. This analysis was pre-specified for the first operative eye only.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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 a glare source or 20/40 Snellen or worse without a glare source
  • Potential for postoperative BCDVA of 20/30 Snellen or better

  • Corneal astigmatism:

    • Normal corneal topography
    • Preoperative corneal astigmatism of 1.00 D or less in both eyes
  • Clear intraocular media other than cataract in each eye
  • Availability, willingness and sufficient cognitive awareness to comply with examination procedures
  • 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:

  • Requiring an intraocular lens power outside the available range of +14.0 D to +26.0 D
  • Any clinically-significant pupil abnormalities (non-reactive, fixed pupils, or abnormally-shaped pupils)
  • Irregular corneal astigmatism
  • Inability to focus or fixate for prolonged periods of time (e.g., due to strabismus, nystagmus, etc.)
  • Prior corneal refractive (LASIK, LASEK, RK, PRK, etc.) or intraocular surgery. Note: Prophylactic peripheral iridotomies and peripheral laser retinal repairs that, in the opinion of the investigator will not confound study outcome or increase risk to the subject, are acceptable.
  • Corneal abnormalities such as stromal, epithelial or endothelial dystrophies that are predicted to cause visual acuity losses to a level worse than 20/30 Snellen during the study
  • Inability to achieve keratometric stability for contact lens wearers (per procedure outlined in Section 10.3)
  • Recent ocular trauma or ocular surgery that is not resolved/stable or 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 losses to a level worse than 20/30 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 may affect vision
  • 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)
  • 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 (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
    • may require surgical intervention during the course of 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 course of the study (macular degeneration, cystoid macular edema, diabetic retinopathy, etc.)
  • 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 60 days prior to preoperative visit in any other clinical trial
  • Desire for monovision correction
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03372434


Locations
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United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
United States, Florida
Katzen Eye Care and Laser Center
Boynton Beach, Florida, United States, 33426
United States, Maryland
Chesapeake Eye Care & Laser Center
Annapolis, Maryland, United States, 21401
Eye Doctors of Washington
Chevy Chase, Maryland, United States, 20815
United States, Pennsylvania
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
United States, South Carolina
Carolina EyeCare Physicians, LLC
Mount Pleasant, South Carolina, United States, 29464
United States, Tennessee
Loden Vision Centers
Goodlettsville, Tennessee, United States, 37072
Eye Specialty Group
Memphis, Tennessee, United States, 38120
United States, Texas
Texas Eye and Laser Center
Hurst, Texas, United States, 76054
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
Focal Point Vision
San Antonio, Texas, United States, 78209
United States, Washington
Clarus Eye Centre
Lacey, Washington, United States, 98503
Sponsors and Collaborators
Abbott Medical Optics
Investigators
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Study Director: Abbott Medical Optics Clinical Trials Abbott Medical Optics
  Study Documents (Full-Text)

Documents provided by Abbott Medical Optics:
Study Protocol  [PDF] December 14, 2017
Statistical Analysis Plan  [PDF] May 16, 2018

More Information
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT03372434    
Other Study ID Numbers: SUR-CAT-652-1001
First Posted: December 13, 2017    Key Record Dates
Results First Posted: July 27, 2021
Last Update Posted: July 27, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases