Post-Approval Study of the Tecnis® Toric IOL
1 other identifier
interventional
365
1 country
44
Brief Summary
This study is a prospective, multicenter, bilateral, non-randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2015
Longer than P75 for not_applicable
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 30, 2015
CompletedFirst Posted
Study publicly available on registry
October 1, 2015
CompletedStudy Start
First participant enrolled
October 21, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 23, 2019
CompletedResults Posted
Study results publicly available
January 18, 2020
CompletedJanuary 18, 2020
January 1, 2020
3.1 years
September 30, 2015
December 10, 2019
January 9, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of Severe Visual Distortions
The rate of severe visual distortions under overall circumstances for the five visual distortion items of interest (lines that slant, tilt, split or separate; flat surfaces appearing curved; objects appearing further away or closer than they are; objects appearing to have a different size or shape; and physical discomfort related to vision). The six month data were used for this endpoint if available and if not an earlier visit was used. If a subject had a lens repositioning the questionnaire prior to the repositioning was used if available.
6 months
Study Arms (2)
non-toric intraocular lens
ACTIVE COMPARATORnon-toric approved intraocular lens
toric intraocular lens
ACTIVE COMPARATORapproved toric intraocular lens
Interventions
Eligibility Criteria
You may qualify if:
- Minimum 22 years of age
- Bilateral cataracts
- Preoperative keratometric cylinder in both eyes
- Most appropriate toric IOL model choice (ZCT300 or ZCT400)
- Predicted residual refractive cylinder, based on the AMO Toric IOL Calculator, must be:
- ≤ 0.69 D for a ZCT300 IOL or ≤ 0.88 D for a ZCT400 IOL
- Clear intraocular media other than cataract in each eye
- Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visits
- Ability to understand, read and write English in order to consent to study participation and complete a study questionnaire
- Signed informed consent and HIPAA authorization
You may not qualify if:
- Irregular corneal astigmatism
- Any corneal pathology/abnormality other than regular corneal astigmatism
- Previous corneal surgery
- Recent ocular trauma or intraocular surgery that is not resolved/stable or may affect visual outcomes
- Any pupil abnormalities
- Subjects with conditions associated with increased risk of zonular rupture, including capsular or zonular abnormalities that may lead to IOL decentration, including pseudoexfoliation, trauma, or posterior capsule defects
- Known ocular disease or pathology that may affect visual acuity or that may require surgical intervention during the course of the study
- Concurrent participation or participation during 30 days prior to preoperative visit in any other clinical study
- Planned monovision correction
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (44)
Eye Center South
Dothan, Alabama, 36301, United States
Arizona Eye Cente
Chandler, Arizona, 85225, United States
Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
Tucson, Arizona, 85704, United States
Boozman-Hof Regional Eye Clinic
Rogers, Arkansas, 72757, United States
Empire Eye & Laser Center
Bakersfield, California, 93309, United States
Atlantis Eye Care
Huntington Beach, California, 92647, United States
Scripps Clinic Medical Group
La Jolla, California, 92037, United States
Southern California Eye Physicians & Associates
Long Beach, California, 90805, United States
Feinerman Vision Center
Newport Beach, California, 92663, United States
Coastal Vision
Orange, California, 92868, United States
California Eye Medical Specialists
Pasadena, California, 91107, United States
Wolstan & Goldberg Eye Associates
Torrance, California, 90505, United States
Florida Eye Microsurgical Institute, Inc.
Boynton Beach, Florida, 33426, United States
Katzen Eye Care & Laser Center
Boynton Beach, Florida, 33426, United States
The Eye Associates
Bradenton, Florida, 34209, United States
Cape Coral Eye Center
Cape Coral, Florida, 336904, United States
Levenson Eye Associates, Inc.
Jacksonville, Florida, 32204, United States
Northwestern University Feinberg School of Medicine
Chicago, Illinois, 60611, United States
Virdi Eye Clinic & Laser Vision Center
Rock Island, Illinois, 61201, United States
Senior Health Services
Louisville, Kentucky, 40220, United States
Chesapeake Eye Care and Laser Center
Annapolis, Maryland, 21401, United States
Solomon Eye Associates
Bowie, Maryland, 20716, United States
Eye Doctors of Washington
Chevy Chase, Maryland, 20815, United States
Oakland Ophthalmic Surgery, P.C.
Birmingham, Michigan, 48009, United States
TLC Eye Care and Laser Centers
Chelsea, Michigan, 48118, United States
Mercy Clinic Eye Specialist
Springfield, Missouri, 65804, United States
Ophthalmology Associates
St Louis, Missouri, 63131, United States
Ophthalmology Consultants
St Louis, Missouri, 63131, United States
Kindermann Eye Associates
Cherry Hill, New Jersey, 08002, United States
Matossian Eye Associates
Pennington, New Jersey, 08534, United States
Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Pamel Vision & Laser Group
New York, New York, 10065, United States
Fine, Hoffman & Sims
Eugene, Oregon, 97401, United States
The Eye Center of Central PA
Allenwood, Pennsylvania, 17810, United States
Ludwick Eye Center
Chambersburg, Pennsylvania, 17201, United States
Scott & Christie and Associates, PC
Cranberry Township, Pennsylvania, 16066, United States
Carolina Cataract & Laser Center
Ladson, South Carolina, 29456, United States
Vance Thompson Vision
Sioux Falls, South Dakota, 57105, United States
Loden Vision Centers
Goodlettsville, Tennessee, 37072, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Whitsett Vision Group
Houston, Texas, 77055, United States
Focal Point Vision
San Antonio, Texas, 78229, United States
San Antonio Eye Specialists
San Antonio, Texas, 78248, United States
Clarus Eye Centre
Lacey, Washington, 98503, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Devi Priya Janakiraman, OD, FAAO
- Organization
- Johnson & Johnson Surgical Vision
Study Officials
- STUDY DIRECTOR
Devi Priya Janakiraman, OD, FAAO
Johnson & Johnson Surgical Vision
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 30, 2015
First Posted
October 1, 2015
Study Start
October 21, 2015
Primary Completion
December 11, 2018
Study Completion
May 23, 2019
Last Updated
January 18, 2020
Results First Posted
January 18, 2020
Record last verified: 2020-01
Data Sharing
- IPD Sharing
- Will not share