Post-Approval Study of the TECNIS® Toric Extended Cylinder Range Intraocular Lens (IOL)

Cataract Clinical Trial

Official title:

Post-Approval Study of the TECNIS® Toric IOL Extended Cylinder Range (ECR), Models ZCT450, ZCT525 and ZCT600

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02649842
• Other study ID #: TIOL-204-EPAS
• Status: Completed
• Phase: N/A
• Start date: March 21, 2016
• Est. completion date: January 28, 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, clinical study conducted at up to 20 sites in the USA. Subjects were to be bilaterally implanted with one eye having an extended cylinder (high cylinder) toric IOL (model ZCT450, ZCT525 or ZCT600) and the fellow eye having a high cylinder toric IOL (model ZCT450, ZCT525 or ZCT600) or a lower cylinder toric IOL (ZCT300 or ZCT400). This study evaluates the outcomes for subjects implanted with at least one higher cylinder toric IOL.

Description:

The purpose of this study is to evaluate the performance of the higher cylinder (ZCT450,ZCT525 and ZCT600) toric IOLs. Some subjects had the higher cylinder toric IOLs in both eyes with other subjects having a higher cylinder toric IOL in one eye and the lower cylinder toric IOL in the other eye.

Per the statistical plan, data for the ZCT450/525/600 toric IOLs were to be pooled together and reported as one group.

The primary endpoint is the rate of severe visual distortions reported by subject at 6 months via questionnaire. The analysis population for this endpoint will be bilaterally implanted subjects with a high cylinder IOL (ZCT450/525/600) in the primary eye and a high cylinder IOL (ZCT450/525/600) or a low cylinder IOL (ZCT300/400) in the fellow eye.

There were no formal secondary endpoints. Data from a few other endpoints (rate of IOL repositioning due to IOL misalignment and percent change in cylinder) have been reported. For these endpoints the analysis population contains all subjects implanted with a ZCT450/525/600 in at least one eye.

Adverse events were reported by subject for all subjects with a high cylinder IOL (ZCT450/525/600) in at least one eye.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: January 28, 2019
• Est. primary completion date: August 27, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

• Minimum 22 years of age

• Bilateral cataracts

• Preoperative keratometric cylinder of at least 2.00 D in both eyes with at least one eye having approximately 3.00 D to 4.75 D of corneal astigmatism.

• 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 or 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

• 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 or is lactating

Related Conditions & MeSH terms

• Astigmatism
• Cataract

Intervention

Device:
• TECNIS Toric Models ZCT450, ZCT525 or ZCT600
Approved toric intraocular lens

Locations

Country	Name	City	State
United States	Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Chesapeake Eye Care and Laser Center	Annapolis	Maryland
United States	Katzen Eye Care & Laser Center	Boynton Beach	Florida
United States	Arizona Eye Center	Chandler	Arizona
United States	Kindermann Eye Associates	Cherry Hill	New Jersey
United States	Eye Doctors of Washington	Chevy Chase	Maryland
United States	Eye Center South	Dothan	Alabama
United States	Texas Eye and Laser Center	Hurst	Texas
United States	Levenson Eye Associates, Inc.	Jacksonville	Florida
United States	Scripps Clinical 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	Carolina Eyecare Physicians, LLC	Pleasant	South Carolina
United States	Virdi Eye Clinic & Laser Vision Center	Rock Island	Illinois
United States	Vance Thompson Vision	Sioux Falls	South Dakota
United States	Mercy Research	Springfield	Missouri
United States	Fishkind, Bakewell & Maltzman Eye Care & Surgery Center	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
Other	Rate of IOL Repositioning Due to IOL Misalignment	Rate of IOL repositioning due to IOL misalignment in primary and fellow eyes with a high cylinder toric IOL	6 months
Other	Percent Change in Cylinder	Percent change in cylinder= ((postop refractive cylinder-preop keratometric cylinder) / (Target refractive cylinder-preop keratometric cylinder))*100	6 months
Primary	Rate of Severe Visual Distortions	Rate of severe visual distortions based on data from a self administered subject questionnaire	6 months