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

Last updated: April 25, 2025
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Overall Status: Active - Recruiting

Phase

N/A

Condition

Vision Loss

Presbyopia

Eye Disorders/infections

Treatment

Intervention

Clinical Study ID

NCT06250322
PCOL204APME
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients who are bilaterally implanted with TECNIS PC IOL and are at least 45 dayspostoperative from their second eye surgery

  • Clear intraocular media

  • Signed informed consent and data protection documentation

  • Availability, willingness, ability, and sufficient cognitive awareness to complywith examination procedures

  • Ability to understand, read, and write English or the local language in which theinformed consent and questionnaires are provided

Exclusion

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 confoundresults

  • Patients with amblyopia, strabismus, nystagmus

  • Concurrent participation in another clinical trial

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: Intervention
Phase:
Study Start date:
April 10, 2024
Estimated Completion Date:
June 02, 2025

Connect with a study center

  • Vision Eye Institute

    Chatswood, New South Wales 2067
    Australia

    Active - Recruiting

  • Sunshine Eye Clinic

    Birtinya, Queensland 4575
    Australia

    Active - Recruiting

  • The Queensland Eye Institute Foundation

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Lions Eye Institute

    Nedlands, Western Australia 6009
    Australia

    Active - Recruiting

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

    Vienna, 1140
    Austria

    Completed

  • CHU Morvan Brest

    Brest, 29609
    France

    Site Not Available

  • Clinique Juge Marseille

    Marseille, 13008
    France

    Active - Recruiting

  • Augenklinik Ahaus GmbH & Co. KG

    Ahaus, 48683
    Germany

    Active - Recruiting

  • Uni Bochum

    Bochum, 44892
    Germany

    Site Not Available

  • Augenklinik Dardenne

    Bonn, 53177
    Germany

    Active - Recruiting

  • Narayana Nethralaya

    Bangalore 560010,
    India

    Active - Recruiting

  • The Eye Foundation

    Coimbatore 641002,
    India

    Active - Recruiting

  • Centre for Sight Eye Institute

    New Delhi, 110029
    India

    Active - Recruiting

  • All India Institute of Medical Sciences (AIIMS)

    New Delhi 110029,
    India

    Active - Recruiting

  • Kangbuk Samsung

    Seoul, 3181
    Korea, Republic of

    Site Not Available

  • Kim's eye clinic

    Seoul, 7301
    Korea, Republic of

    Site Not Available

  • Korea Uni.Kuro

    Seoul, 8308
    Korea, Republic of

    Site Not Available

  • Severance

    Seoul, 3722
    Korea, Republic of

    Site Not Available

  • Amphia Ziekenhuis

    Breda, 4800 RK
    Netherlands

    Site Not Available

  • Oogziekenhuis Rotterdam

    Rotterdam, 3011 BH
    Netherlands

    Active - Recruiting

  • ETZ

    Tilburg, 5022 GC
    Netherlands

    Completed

  • Terrace Eye Centre Wellington

    Wellington, 6011
    New Zealand

    Site Not Available

  • Clinica Oftalmologica Diez del Corral

    Madrid, 28016
    Spain

    Completed

  • Mirzana IOA

    Madrid, 28035
    Spain

    Site Not Available

  • Vithas Alicante

    Madrid, 28043
    Spain

    Active - Recruiting

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