NCT02203721

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
324

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2014

Shorter than P25 for not_applicable

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 24, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 11, 2017

Completed
Last Updated

January 11, 2017

Status Verified

November 1, 2016

Enrollment Period

9 months

First QC Date

July 24, 2014

Results QC Date

September 28, 2016

Last Update Submit

November 15, 2016

Conditions

Cataract

Outcome Measures

Primary Outcomes (2)

  • Distance Corrected Intermediate Visual Acuity

    FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.

    At 6 months

  • Uncorrected Intermediate Visual Acuity

    Uncorrected Intermediate Visual Acuity at 6 months.

    6 months

Study Arms (2)

TECNIS Symfony Extended Range of Vision IOL, Model ZXR00

EXPERIMENTAL

Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00

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

TECNIS Monofocal IOL, Model ZCB00

ACTIVE COMPARATOR

Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00

Device: TECNIS Monofocal IOL, Model ZCB00

Interventions

TECNIS Symfony Extended Range of Vision IOL, Model ZXR00DEVICE
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
TECNIS Monofocal IOL, Model ZCB00DEVICE
TECNIS Monofocal IOL, Model ZCB00

Eligibility Criteria

Age22 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Boozman-Hof Regional Eye Clinic

Rogers, Arkansas, 72756, United States

Location

Empire Eye & Laser Center

Bakersfield, California, 93309, United States

Location

Katzen Eye Care & Laser Center

Boynton Beach, Florida, 33426, United States

Location

Cape Coral Eye Center

Cape Coral, Florida, 33904, United States

Location

Virdi Eye Clinic & Laser Vision Center

Rock Island, Illinois, 61201, United States

Location

Eye Surgeons of Indiana

Indianapolis, Indiana, 46256, United States

Location

Jones Eye Clinic

Sioux City, Iowa, 51104, United States

Location

Eye Doctors of Washington

Chevy Chase, Maryland, 20815, United States

Location

Ophthalmic Consultants of Long Island

Rockville Centre, New York, 11570, United States

Location

The Eye Center of Central PA

Allenwood, Pennsylvania, 17810, United States

Location

Scott & Christie and Associates, PC

Cranberry Township, Pennsylvania, 16066, United States

Location

Loden Vision Center

Goodlettsville, Tennessee, 37072, United States

Location

Whitsett Vision Group

Houston, Texas, 77055, United States

Location

Texas Eye and Laser Center

Hurst, Texas, 76054, United States

Location

Lehmann Eye Center

Nacogdoches, Texas, 75965, United States

Location

Related Publications (1)

  • Chang DH, Janakiraman DP, Smith PJ, Buteyn A, Domingo J, Jones JJ, Christie WC. Visual outcomes and safety of an extended depth-of-focus intraocular lens: results of a pivotal clinical trial. J Cataract Refract Surg. 2022 Mar 1;48(3):288-297. doi: 10.1097/j.jcrs.0000000000000747.

    PMID: 34269326DERIVED

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Results Point of Contact

Title
Kendra Hileman, Ph.D., Director of Clinical Research and Development
Organization
Abbott Medical Optics
kendra.hileman@abbott.com
714-247-8613

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 24, 2014

First Posted

July 30, 2014

Study Start

September 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 11, 2017

Results First Posted

January 11, 2017

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

US(15)