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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

Tracking Information
First Submitted Date  ICMJE December 8, 2017
First Posted Date  ICMJE December 13, 2017
Results First Submitted Date  ICMJE May 19, 2021
Results First Posted Date  ICMJE July 27, 2021
Last Update Posted Date July 27, 2021
Actual Study Start Date  ICMJE January 16, 2018
Actual Primary Completion Date July 11, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 7, 2021)
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.
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation of the Next-Generation Intraocular Lenses
Official Title  ICMJE Clinical Investigation of the TECNIS Next-Generation Intraocular Lens
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: Investigational Intraocular Lens Device #1: Model ZFR00
    IOL replaces the natural lens removed during cataract surgery.
  • Device: Investigational Intraocular Lens Device #1: Model ZYR00
    IOL replaces the natural lens removed during cataract surgery.
  • Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
    IOL replaces the natural lens removed during cataract surgery.
Study Arms  ICMJE
  • Experimental: Investigational Lens Device #1
    Investigational Intraocular Lens Device #1: Model ZFR00
    Intervention: Device: Investigational Intraocular Lens Device #1: Model ZFR00
  • Experimental: Investigational Lens Device #2
    Investigational Intraocular Lens Device #1: Model ZYR00
    Intervention: Device: Investigational Intraocular Lens Device #1: Model ZYR00
  • Active Comparator: Control Device
    Control TECNIS Multifocal Intraocular Lens Model ZLB00
    Intervention: Device: TECNIS Multifocal Intraocular Lens: Model ZLB00
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 29, 2021)
225
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE October 30, 2018
Actual Primary Completion Date July 11, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03372434
Other Study ID Numbers  ICMJE SUR-CAT-652-1001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Abbott Medical Optics
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Abbott Medical Optics
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Abbott Medical Optics Clinical Trials Abbott Medical Optics
PRS Account Abbott Medical Optics
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP