A Multicenter, Observational, Single Arm Study of the TECNIS Presbyopia-correcting Intraocular Lens

Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.

Study Overview

• Status: Completed
• Conditions: Cataracts
• Intervention / Treatment: Device: Intervention

• Study Type: Observational
• Enrollment (Actual): 307

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Chatswood, New South Wales, Australia, 2067
      • Vision Eye Institute
  • Queensland
    • Birtinya, Queensland, Australia, 4575
      • Sunshine Eye Clinic
    • Woolloongabba, Queensland, Australia, 4102
      • The Queensland Eye Institute Foundation
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • Lions Eye Institute
• Austria
  • Vienna, Austria, 1140
    • Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
• France
  • Brest, France, 29609
    • CHU Morvan Brest
  • Marseille, France, 13008
    • Clinique Juge Marseille
• Germany
  • Ahaus, Germany, 48683
    • Augenklinik Ahaus GmbH & Co. KG
  • Bonn, Germany, 53177
    • Augenklinik Dardenne
• India
  • Bengaluru, India
    • Narayana Nethralaya
  • Coimbatore, India
    • The Eye Foundation
  • New Delhi, India
    • All India Institute of Medical Sciences (AIIMS)
  • New Delhi, India, 110029
    • Centre for Sight Eye Institute
• Netherlands
  • Rotterdam, Netherlands, 3011 BH
    • Oogziekenhuis Rotterdam
  • Tilburg, Netherlands, 5022 GC
    • ETZ
• South Korea
  • Seoul, South Korea, 7301
    • Kim's eye clinic
  • Seoul, South Korea, 8308
    • Korea Uni.Kuro
• Spain
  • Madrid, Spain, 28016
    • Clinica Oftalmologica Diez del Corral
  • Madrid, Spain, 28035
    • Mirzana IOA
  • Madrid, Spain, 28043
    • Vithas Alicante

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

A pre-existing population of subjects bilaterally implanted with the PC IOL at approximately 20 sites in Europe and Asia Pacific. Bilateral pseudophakic subjects implanted with the TECNIS PC IOL will be enrolled.

Description

Inclusion Criteria:

• Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 days postoperative from their second eye surgery
• Clear intraocular media
• Signed informed consent and data protection documentation
• Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures
• Ability to understand, read, and write English or the local language in which the informed consent and questionnaires are provided

Exclusion Criteria:

• Subjects with ongoing adverse events that might impact outcomes during the study
• Use of systemic or ocular medication that may affect vision
• Acute or chronic disease or condition, ocular trauma or surgery that may confound results
• Patients with amblyopia, strabismus, nystagmus
• Concurrent participation in another clinical trial

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Symptoms	Patient questionnaires	3month postoperative
Surgeon Experience	Questionnaire	3month postoperative
Visual Acuity	Visual Acuity will be collected with standard clinical charts.	3month postoperative

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): April 10, 2024
• Primary Completion (Actual): June 30, 2025
• Study Completion (Actual): June 30, 2025

Study Registration Dates

• First Submitted: February 1, 2024
• First Submitted That Met QC Criteria: February 1, 2024
• First Posted (Actual): February 9, 2024

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract; Investigative Techniques; Methods
• Other Study ID Numbers: PCOL204APME

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes