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Clinical Investigation of a New Intraocular Lens

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: NCT02203721
Recruitment Status : Completed
First Posted : July 30, 2014
Results First Posted : January 11, 2017
Last Update Posted : January 11, 2017
Sponsor:
Information provided by (Responsible Party):
Abbott Medical Optics

Tracking Information
First Submitted Date  ICMJE July 24, 2014
First Posted Date  ICMJE July 30, 2014
Results First Submitted Date  ICMJE September 28, 2016
Results First Posted Date  ICMJE January 11, 2017
Last Update Posted Date January 11, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 15, 2016)
  • Distance Corrected Intermediate Visual Acuity [ Time Frame: At 6 months ]
    FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
  • Uncorrected Intermediate Visual Acuity [ Time Frame: 6 months ]
    Uncorrected Intermediate Visual Acuity at 6 months.
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 a New Intraocular Lens
Official Title  ICMJE Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
Brief Summary The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cataract
Intervention  ICMJE
  • Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
  • Device: TECNIS Monofocal IOL, Model ZCB00
Study Arms  ICMJE
  • Experimental: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
    Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
    Intervention: 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
    Intervention: Device: TECNIS Monofocal IOL, Model ZCB00
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: November 15, 2016)
324
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date June 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
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 NCT02203721
Other Study ID Numbers  ICMJE EROV-106-ZXRC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Abbott Medical Optics
Study Sponsor  ICMJE Abbott Medical Optics
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Abbott Medical Optics
Verification Date November 2016

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