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

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Locations

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

More Information

• Responsible Party: Abbott Medical Optics
• ClinicalTrials.gov Identifier: NCT02203721
• Other Study ID Numbers: EROV-106-ZXRC
• First Posted: July 30, 2014
• 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:

Cataract; Lens Diseases; Eye Diseases