search
Back to results

Clinical Investigation of a New Intraocular Lens

Primary Purpose

Cataract

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
TECNIS Monofocal IOL, Model ZCB00
Sponsored by
Abbott Medical Optics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cataract

Eligibility Criteria

22 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Boozman-Hof Regional Eye Clinic
  • Empire Eye & Laser Center
  • Katzen Eye Care & Laser Center
  • Cape Coral Eye Center
  • Virdi Eye Clinic & Laser Vision Center
  • Eye Surgeons of Indiana
  • Jones Eye Clinic
  • Eye Doctors of Washington
  • Ophthalmic Consultants of Long Island
  • The Eye Center of Central PA
  • Scott & Christie and Associates, PC
  • Loden Vision Center
  • Whitsett Vision Group
  • Texas Eye and Laser Center
  • Lehmann Eye Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

TECNIS Symfony Extended Range of Vision IOL, Model ZXR00

TECNIS Monofocal IOL, Model ZCB00

Arm Description

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

Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
July 24, 2014
Last Updated
November 15, 2016
Sponsor
Abbott Medical Optics
search

1. Study Identification

Unique Protocol Identification Number
NCT02203721
Brief Title
Clinical Investigation of a New Intraocular Lens
Official Title
Clinical Investigation of the Tecnis Symfony Extended Range of Vision IOL, Model ZXR00
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
September 2014 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott Medical Optics

4. Oversight

Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cataract

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
324 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Arm Type
Experimental
Arm Description
Bilaterally implanted with TECNIS Symfony Extended Range of Vision Intraocular Lens, Model ZXR00
Arm Title
TECNIS Monofocal IOL, Model ZCB00
Arm Type
Active Comparator
Arm Description
Bilaterally implanted with TECNIS Monofocal Intraocular Lens, Model ZCB00
Intervention Type
Device
Intervention Name(s)
TECNIS Symfony Extended Range of Vision IOL, Model ZXR00
Intervention Type
Device
Intervention Name(s)
TECNIS Monofocal IOL, Model ZCB00
Primary Outcome Measure Information:
Title
Distance Corrected Intermediate Visual Acuity
Description
FDA has requested co-primary endpoints of distance corrected and uncorrected intermediate visual acuity.
Time Frame
At 6 months
Title
Uncorrected Intermediate Visual Acuity
Description
Uncorrected Intermediate Visual Acuity at 6 months.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Boozman-Hof Regional Eye Clinic
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72756
Country
United States
Facility Name
Empire Eye & Laser Center
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Katzen Eye Care & Laser Center
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Cape Coral Eye Center
City
Cape Coral
State/Province
Florida
ZIP/Postal Code
33904
Country
United States
Facility Name
Virdi Eye Clinic & Laser Vision Center
City
Rock Island
State/Province
Illinois
ZIP/Postal Code
61201
Country
United States
Facility Name
Eye Surgeons of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Jones Eye Clinic
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Eye Doctors of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Ophthalmic Consultants of Long Island
City
Rockville Center
State/Province
New York
ZIP/Postal Code
11570
Country
United States
Facility Name
The Eye Center of Central PA
City
Allenwood
State/Province
Pennsylvania
ZIP/Postal Code
17810
Country
United States
Facility Name
Scott & Christie and Associates, PC
City
Cranberry Township
State/Province
Pennsylvania
ZIP/Postal Code
16066
Country
United States
Facility Name
Loden Vision Center
City
Goodlettsville
State/Province
Tennessee
ZIP/Postal Code
37072
Country
United States
Facility Name
Whitsett Vision Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
Texas Eye and Laser Center
City
Hurst
State/Province
Texas
ZIP/Postal Code
76054
Country
United States
Facility Name
Lehmann Eye Center
City
Nacogdoches
State/Province
Texas
ZIP/Postal Code
75965
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34269326
Citation
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.
Results Reference
derived

Learn more about this trial

Clinical Investigation of a New Intraocular Lens

We'll reach out to this number within 24 hrs