Clinical trial NCT02566083: Post-Approval Study of the Tecnis® Toric IOL
Official title: Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cataract
Lead sponsor: Abbott Medical Optics
Sponsor class: INDUSTRY
First posted: 2015-10-01
Enrollment: 365
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Rate of Severe Visual Distortions
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Eye Center South
state: Alabama
city: Chandler
country: United States
facility: Arizona Eye Cente
state: Arizona
city: Tucson
country: United States
facility: Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente
state: Arizona
city: Rogers
country: United States
facility: Boozman-Hof Regional Eye Clinic
state: Arkansas
city: Bakersfield
country: United States
facility: Empire Eye & Laser Center
state: California
city: Huntington Beach
country: United States
facility: Atlantis Eye Care
state: California
city: La Jolla
country: United States
facility: Scripps Clinic Medical Group
state: California
city: Long Beach
country: United States
facility: Southern California Eye Physicians & Associates
state: California
city: Newport Beach
country: United States
facility: Feinerman Vision Center
state: California
city: Orange
country: United States
facility: Coastal Vision
state: California
city: Pasadena
country: United States
facility: California Eye Medical Specialists
state: California
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Boynton Beach
country: United States
facility: Florida Eye Microsurgical Institute, Inc.
state: Florida
city: Boynton Beach
country: United States
facility: Katzen Eye Care & Laser Center
state: Florida
city: Bradenton
country: United States
facility: The Eye Associates
state: Florida
city: Cape Coral
country: United States
facility: Cape Coral Eye Center
state: Florida
city: Jacksonville
country: United States
facility: Levenson Eye Associates, Inc.
state: Florida
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine
state: Illinois
city: Rock Island
country: United States
facility: Virdi Eye Clinic & Laser Vision Center
state: Illinois
city: Louisville
country: United States
facility: Senior Health Services
state: Kentucky
city: Annapolis
country: United States
facility: Chesapeake Eye Care and Laser Center
state: Maryland
city: Bowie
country: United States
facility: Solomon Eye Associates
state: Maryland
city: Chevy Chase
country: United States
facility: Eye Doctors of Washington
state: Maryland
city: Birmingham
country: United States
facility: Oakland Ophthalmic Surgery, P.C.
state: Michigan
city: Chelsea
country: United States
facility: TLC Eye Care and Laser Centers
state: Michigan
city: Saint Louis
country: United States
facility: Ophthalmology Associates
state: Missouri
city: Saint Louis
country: United States
facility: Ophthalmology Consultants
state: Missouri
city: Springfield
country: United States
facility: Mercy Clinic Eye Specialist
state: Missouri
city: Cherry Hill
country: United States
facility: Kindermann Eye Associates
state: New Jersey
city: Pennington
country: United States
facility: Matossian Eye Associates
state: New Jersey
city: Albuquerque
country: United States
facility: Eye Associates of New Mexico
state: New Mexico
city: New York
country: United States
facility: Pamel Vision & Laser Group
state: New York
city: Eugene
country: United States
facility: Fine, Hoffman & Sims
state: Oregon
city: Allenwood
country: United States
facility: The Eye Center of Central PA
state: Pennsylvania
city: Chambersburg
country: United States
facility: Ludwick Eye Center
state: Pennsylvania
city: Cranberry Township
country: United States
facility: Scott & Christie and Associates, PC
state: Pennsylvania
city: Ladson
country: United States
facility: Carolina Cataract & Laser Center
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
city: Goodlettsville
country: United States
facility: Loden Vision Centers
state: Tennessee
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Whitsett Vision Group
state: Texas
city: San Antonio
country: United States
facility: Focal Point Vision
state: Texas
city: San Antonio
country: United States
facility: San Antonio Eye Specialists
state: Texas
city: Lacey
country: United States
facility: Clarus Eye Centre
state: Washington
Study officials:
affiliation: Johnson & Johnson Surgical Vision
name: Devi Priya Janakiraman, OD, FAAO
role: STUDY_DIRECTOR
References: