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

NCT ID: NCT02649842

Last Updated: 2025-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 101 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-21
• Study Completion Date: 2019-01-28

Brief 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.

Detailed 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.

Conditions

Cataract; Astigmatism

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Extended Cylinder IOL

Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600

Group Type: EXPERIMENTAL

TECNIS Toric Models ZCT450, ZCT525 or ZCT600

Intervention Type: DEVICE

Approved toric intraocular lens

Interventions

TECNIS Toric Models ZCT450, ZCT525 or ZCT600

Approved toric intraocular lens

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 22 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Abbott Medical Optics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Devi Priya Janakiraman, OD,FAAO

Role: STUDY_DIRECTOR

Abbott Medical Optics

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

TIOL-204-EPAS

Identifier Type: -

Identifier Source: org_study_id