Clinical Investigation of a New Intraocular Lens

Not Applicable

Completed

Conditions: Cataract

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

Registration Number: NCT02203721

Lead Sponsor: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 324

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00	TECNIS Symfony Extended Range of Vision IOL, Model ZXR00	Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
TECNIS Monofocal IOL, Model ZCB00	TECNIS Monofocal IOL, Model ZCB00	Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00

Primary Outcome Measures

Name	Time	Method
Distance Corrected Intermediate Visual Acuity	At 6 months	FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Uncorrected Intermediate Visual Acuity	6 months	Uncorrected Intermediate Visual Acuity at 6 months.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (15): Virdi Eye Clinic & Laser Vision Center
🇺🇸
Rock Island, Illinois, United States
Empire Eye & Laser Center
🇺🇸
Bakersfield, California, United States
Jones Eye Clinic
🇺🇸
Sioux City, Iowa, United States
Eye Surgeons of Indiana
🇺🇸
Indianapolis, Indiana, United States
Ophthalmic Consultants of Long Island
🇺🇸
Rockville Center, New York, United States
Scott & Christie and Associates, PC
🇺🇸
Cranberry Township, Pennsylvania, United States
Whitsett Vision Group
🇺🇸
Houston, Texas, United States
Texas Eye and Laser Center
🇺🇸
Hurst, Texas, United States
Lehmann Eye Center
🇺🇸
Nacogdoches, Texas, United States
The Eye Center of Central PA
🇺🇸
Allenwood, Pennsylvania, United States
Eye Doctors of Washington
🇺🇸
Chevy Chase, Maryland, United States
Katzen Eye Care & Laser Center
🇺🇸
Boynton Beach, Florida, United States
Loden Vision Center
🇺🇸
Goodlettsville, Tennessee, United States
Boozman-Hof Regional Eye Clinic
🇺🇸
Rogers, Arkansas, United States
Cape Coral Eye Center
🇺🇸
Cape Coral, Florida, United States