Post-Approval Study of the Tecnis® Toric IOL

Cataract Clinical Trial

Official title:

Post-Approval Study of the Tecnis® Toric IOL, Models ZCT300 and ZCT400

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02566083
• Other study ID #: TIOL-202-TPAS
• Status: Completed
• Phase: N/A
• Start date: October 21, 2015
• Est. completion date: May 23, 2019

Study information

• Verified date: January 2020
• Source: Abbott Medical Optics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 365
• Est. completion date: May 23, 2019
• Est. primary completion date: December 11, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cataract

Intervention

Device:
• non-toric intraocular lens
TECNIS One-piece Monofocal Model ZCB00
• toric intraocular lens
TECNIS One-piece Toric Models ZCT300 or ZCT400

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Optics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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