Clinical Investigation of a New Intraocular Lens

• 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: Abbott Medical Optics
• Information provided by (Responsible Party): Abbott Medical Optics

Tracking Information

• First Submitted Date: July 24, 2014
• First Posted Date: July 30, 2014
• Results First Submitted Date: September 28, 2016
• Results First Posted Date: January 11, 2017
• Last Update Posted Date: January 11, 2017
• Study Start Date: September 2014
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Clinical Investigation of a New Intraocular Lens
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Cataract

Intervention

• Device: TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
• Device: TECNIS Monofocal IOL, Model ZCB00

Study Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 15, 2016): 324
• Original Enrollment: Not Provided
• Actual Study Completion Date: June 2015
• Actual Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 22 Years to 99 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02203721
• Other Study ID Numbers: EROV-106-ZXRC
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Abbott Medical Optics
• Study Sponsor: Abbott Medical Optics
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Abbott Medical Optics
• Verification Date: November 2016