NCT06250322

Brief Summary

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
307

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
7 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 1, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 9, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

April 10, 2024

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2025

Completed
Last Updated

June 5, 2026

Status Verified

June 1, 2026

Enrollment Period

1.2 years

First QC Date

February 1, 2024

Last Update Submit

June 4, 2026

Conditions

Cataracts

Outcome Measures

Primary Outcomes (3)

  • Visual Symptoms

    Patient questionnaires

    3month postoperative

  • Surgeon Experience

    Questionnaire

    3month postoperative

  • Visual Acuity

    Visual Acuity will be collected with standard clinical charts.

    3month postoperative

Interventions

InterventionDEVICE

No study treatments will be administered during this study. However, data will be collected from medical records of patients who have been treated with the subject device of this study.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

Vision Eye Institute

Chatswood, New South Wales, 2067, Australia

Location

Sunshine Eye Clinic

Birtinya, Queensland, 4575, Australia

Location

The Queensland Eye Institute Foundation

Woolloongabba, Queensland, 4102, Australia

Location

Lions Eye Institute

Nedlands, Western Australia, 6009, Australia

Location

Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute

Vienna, 1140, Austria

Location

CHU Morvan Brest

Brest, 29609, France

Location

Clinique Juge Marseille

Marseille, 13008, France

Location

Augenklinik Ahaus GmbH & Co. KG

Ahaus, 48683, Germany

Location

Augenklinik Dardenne

Bonn, 53177, Germany

Location

Narayana Nethralaya

Bengaluru, India

Location

The Eye Foundation

Coimbatore, India

Location

Centre for Sight Eye Institute

New Delhi, 110029, India

Location

All India Institute of Medical Sciences (AIIMS)

New Delhi, India

Location

Oogziekenhuis Rotterdam

Rotterdam, 3011 BH, Netherlands

Location

ETZ

Tilburg, 5022 GC, Netherlands

Location

Kim's eye clinic

Seoul, 7301, South Korea

Location

Korea Uni.Kuro

Seoul, 8308, South Korea

Location

Clinica Oftalmologica Diez del Corral

Madrid, 28016, Spain

Location

Mirzana IOA

Madrid, 28035, Spain

Location

Vithas Alicante

Madrid, 28043, Spain

Location

MeSH Terms

Conditions

Cataract

Interventions

Methods

Condition Hierarchy (Ancestors)

Lens DiseasesEye Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Johnson & Johnson Surgical Vision, Inc. Clinical Trial

    Johnson & Johnson Surgical Vision, Inc.

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 1, 2024

First Posted

February 9, 2024

Study Start

April 10, 2024

Primary Completion

June 30, 2025

Study Completion

June 30, 2025

Last Updated

June 5, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will share

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

More information

Locations

NL(2)FR(2)DE(2)AU(1)ES(3)KR(2)IN(4)