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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

Brief Summary:
The purpose of this clinical trial is to evaluate the safety and effectiveness of the TECNIS Symfony Extended Range of Vision IOL.

Condition or disease Intervention/treatment Phase
Cataract Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00 Device: TECNIS Monofocal IOL, Model ZCB00 Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 324 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
Study Start Date : September 2014
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Arm Intervention/treatment
Experimental: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
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
Device: TECNIS Monofocal IOL, Model ZCB00



Primary Outcome Measures :
  1. Distance Corrected Intermediate Visual Acuity [ Time Frame: At 6 months ]
    FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.

  2. Uncorrected Intermediate Visual Acuity [ Time Frame: 6 months ]
    Uncorrected Intermediate Visual Acuity at 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   22 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02203721


Locations
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United States, Arkansas
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, United States, 72756
United States, California
Empire Eye & Laser Center
Bakersfield, California, United States, 93309
United States, Florida
Katzen Eye Care & Laser Center
Boynton Beach, Florida, United States, 33426
Cape Coral Eye Center
Cape Coral, Florida, United States, 33904
United States, Illinois
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, United States, 61201
United States, Indiana
Eye Surgeons of Indiana
Indianapolis, Indiana, United States, 46256
United States, Iowa
Jones Eye Clinic
Sioux City, Iowa, United States, 51104
United States, Maryland
Eye Doctors of Washington
Chevy Chase, Maryland, United States, 20815
United States, New York
Ophthalmic Consultants of Long Island
Rockville Center, New York, United States, 11570
United States, Pennsylvania
The Eye Center of Central PA
Allenwood, Pennsylvania, United States, 17810
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, United States, 16066
United States, Tennessee
Loden Vision Center
Goodlettsville, Tennessee, United States, 37072
United States, Texas
Whitsett Vision Group
Houston, Texas, United States, 77055
Texas Eye and Laser Center
Hurst, Texas, United States, 76054
Lehmann Eye Center
Nacogdoches, Texas, United States, 75965
Sponsors and Collaborators
Abbott Medical Optics
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Responsible Party: Abbott Medical Optics
ClinicalTrials.gov Identifier: NCT02203721    
Other Study ID Numbers: EROV-106-ZXRC
First Posted: July 30, 2014    Key Record Dates
Results First Posted: January 11, 2017
Last Update Posted: January 11, 2017
Last Verified: November 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Cataract
Lens Diseases
Eye Diseases