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

NCT02649842 | Completed Results

• 1 other identifier: TIOL-204-EPAS
• Study Type: interventional
• Target: 101
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cataract; Astigmatism

Outcome Measures

Primary Outcomes (1)

• Rate of Severe Visual Distortions

  Rate of severe visual distortions based on data from a self administered subject questionnaire

  6 months

Other Outcomes (2)

• Rate of IOL Repositioning Due to IOL Misalignment

  6 months

• Percent Change in Cylinder

  6 months

Study Arms (1)

Extended Cylinder IOL

EXPERIMENTAL

Approved toric intraocular lenses, Model ZCT450, ZCT525 or ZCT600

Device: TECNIS Toric Models ZCT450, ZCT525 or ZCT600

Interventions

TECNIS Toric Models ZCT450, ZCT525 or ZCT600 DEVICE

Approved toric intraocular lens

Extended Cylinder IOL

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Abbott Medical Optics: lead

MeSH Terms

Conditions

Cataract; Astigmatism

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases; Refractive Errors

Results Point of Contact

• Title: Devi Priya Janakiraman, OD, FAAO
• Organization: Johnson & Johnson Surgical Vision

djanaki1@its.jnj.com

1+ 714-247-8429

Study Officials

• Devi Priya Janakiraman, OD,FAAO

  Abbott Medical Optics

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2016
• First Posted: January 8, 2016
• Study Start: March 21, 2016
• Primary Completion: August 27, 2018
• Study Completion: January 28, 2019
• Last Updated: February 4, 2025
• Results First Posted: December 27, 2019

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share