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

April 23, 2024 updated by: Johnson & Johnson Surgical Vision, Inc.
Ambispective post-market data collection on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PC IOL.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Austria
      • Vienna, Austria, 1140
        • Not yet recruiting
        • Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute
        • Contact:
        • Principal Investigator:
          • Oliver Findl
  • France
      • Brest, France, 29609
        • Not yet recruiting
        • CHU Morvan Brest
        • Contact:
        • Principal Investigator:
          • Beatrice Cochener
      • Marseille, France, 13008
        • Not yet recruiting
        • Clinique Juge Marseille
        • Contact:
        • Principal Investigator:
          • Pascal Rozot
  • Germany
      • Ahaus, Germany, 48683
        • Not yet recruiting
        • Augenklinik Ahaus GmbH & Co. KG
        • Principal Investigator:
          • Matthias Gerl
      • Bonn, Germany, 53177
        • Not yet recruiting
        • Augenklinik Dardenne
        • Contact:
        • Principal Investigator:
          • Alireza Mirshahi
  • Korea, Republic of
      • Seoul, Korea, Republic of, 7301
        • Not yet recruiting
        • Kim's eye clinic
        • Contact:
        • Principal Investigator:
          • HW Tchah
      • Seoul, Korea, Republic of, 8308
        • Not yet recruiting
        • Korea Uni.Kuro
        • Contact:
        • Principal Investigator:
          • Jong Suk Song
  • Netherlands
      • Rotterdam, Netherlands, 3011 BH
        • Not yet recruiting
        • Oogziekenhuis Rotterdam
        • Principal Investigator:
          • Yassi Sharifi
      • Tilburg, Netherlands, 5022 GC
        • Not yet recruiting
        • ETZ
        • Contact:
        • Principal Investigator:
          • Oege Goslings
  • Spain
      • Madrid, Spain, 28016
        • Recruiting
        • Clinica Oftalmologica Diez del Corral
        • Contact:
        • Principal Investigator:
          • José Manuel Díez del Corral Belda
      • Madrid, Spain, 28035
        • Not yet recruiting
        • Mirzana IOA
        • Contact:
        • Principal Investigator:
          • Félix G López
      • Madrid, Spain, 28043
        • Not yet recruiting
        • Vithas Alicante
        • Contact:
        • Principal Investigator:
          • Alfonso Arias Puente

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johnson & Johnson Surgical Vision, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 10, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

March 1, 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)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 23, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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