Post-Approval Study of the Tecnis® Toric IOL

Not Applicable

Completed

• Conditions: Cataract
• Interventions: Device: toric intraocular lens; Device: non-toric intraocular lens

• Registration Number: NCT02566083
• Lead Sponsor: Abbott Medical Optics

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-09-30
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Study Start: 2015-10-21
• Primary Completion: 2018-12-11
• Study Completion: 2019-05-23
• Results First Submitted: 2019-12-10
• Status Verified: 2020-01
• Results First Submitted QC: 2020-01-09
• Last Update Submitted: 2020-01-09
• Results First Posted: 2020-01-18
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 365

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
toric intraocular lens	toric intraocular lens	approved toric intraocular lens
non-toric intraocular lens	non-toric intraocular lens	non-toric approved intraocular lens

Primary Outcome Measures

Name	Time	Method
Rate of Severe Visual Distortions	6 months	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.

Trial Locations

Locations (44)

Loden Vision Centers; 🇺🇸 Goodlettsville, Tennessee, United States

Eye Center South; 🇺🇸 Dothan, Alabama, United States

Arizona Eye Cente; 🇺🇸 Chandler, Arizona, United States

Fishkind, Bakewell & Maltzman Eye Care & Surgery Cente; 🇺🇸 Tucson, Arizona, United States

Boozman-Hof Regional Eye Clinic; 🇺🇸 Rogers, Arkansas, United States

Empire Eye & Laser Center; 🇺🇸 Bakersfield, California, United States

Atlantis Eye Care; 🇺🇸 Huntington Beach, California, United States

Southern California Eye Physicians & Associates; 🇺🇸 Long Beach, California, United States

Feinerman Vision Center; 🇺🇸 Newport Beach, California, United States

Scripps Clinic Medical Group; 🇺🇸 La Jolla, California, United States

Coastal Vision; 🇺🇸 Orange, California, United States

Wolstan & Goldberg Eye Associates; 🇺🇸 Torrance, California, United States

California Eye Medical Specialists; 🇺🇸 Pasadena, California, United States

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

Katzen Eye Care & Laser Center; 🇺🇸 Boynton Beach, Florida, United States

Levenson Eye Associates, Inc.; 🇺🇸 Jacksonville, Florida, United States

The Eye Associates; 🇺🇸 Bradenton, Florida, United States

Florida Eye Microsurgical Institute, Inc.; 🇺🇸 Boynton Beach, Florida, United States

Cape Coral Eye Center; 🇺🇸 Cape Coral, Florida, United States

Virdi Eye Clinic & Laser Vision Center; 🇺🇸 Rock Island, Illinois, United States

Chesapeake Eye Care and Laser Center; 🇺🇸 Annapolis, Maryland, United States

Solomon Eye Associates; 🇺🇸 Bowie, Maryland, United States

TLC Eye Care and Laser Centers; 🇺🇸 Chelsea, Michigan, United States

Ophthalmology Associates; 🇺🇸 Saint Louis, Missouri, United States

Oakland Ophthalmic Surgery, P.C.; 🇺🇸 Birmingham, Michigan, United States

Ophthalmology Consultants; 🇺🇸 Saint Louis, Missouri, United States

Kindermann Eye Associates; 🇺🇸 Cherry Hill, New Jersey, United States

Mercy Clinic Eye Specialist; 🇺🇸 Springfield, Missouri, United States

Matossian Eye Associates; 🇺🇸 Pennington, New Jersey, United States

Eye Associates of New Mexico; 🇺🇸 Albuquerque, New Mexico, United States

Pamel Vision & Laser Group; 🇺🇸 New York, New York, United States

Ludwick Eye Center; 🇺🇸 Chambersburg, Pennsylvania, United States

Fine, Hoffman & Sims; 🇺🇸 Eugene, Oregon, United States

The Eye Center of Central PA; 🇺🇸 Allenwood, Pennsylvania, United States

Scott & Christie and Associates, PC; 🇺🇸 Cranberry Township, Pennsylvania, United States

Carolina Cataract & Laser Center; 🇺🇸 Ladson, South Carolina, United States

Vance Thompson Vision; 🇺🇸 Sioux Falls, South Dakota, United States

Clarus Eye Centre; 🇺🇸 Lacey, Washington, United States

Houston Eye Associates; 🇺🇸 Houston, Texas, United States

Whitsett Vision Group; 🇺🇸 Houston, Texas, United States

Focal Point Vision; 🇺🇸 San Antonio, Texas, United States

Senior Health Services; 🇺🇸 Louisville, Kentucky, United States

San Antonio Eye Specialists; 🇺🇸 San Antonio, Texas, United States

Eye Doctors of Washington; 🇺🇸 Chevy Chase, Maryland, United States