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

NCT ID: NCT06250322

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

307 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-04-10

Study Completion Date

2025-06-30

Brief Summary

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

Detailed Description

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Conditions

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Cataracts

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Interventions

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Intervention

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.

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson Surgical Vision, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Johnson & Johnson Surgical Vision, Inc. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Surgical Vision, Inc.

Locations

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Vision Eye Institute

Chatswood, New South Wales, Australia

Site Status

Sunshine Eye Clinic

Birtinya, Queensland, Australia

Site Status

The Queensland Eye Institute Foundation

Woolloongabba, Queensland, Australia

Site Status

Lions Eye Institute

Nedlands, Western Australia, Australia

Site Status

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

Vienna, , Austria

Site Status

CHU Morvan Brest

Brest, , France

Site Status

Clinique Juge Marseille

Marseille, , France

Site Status

Augenklinik Ahaus GmbH & Co. KG

Ahaus, , Germany

Site Status

Augenklinik Dardenne

Bonn, , Germany

Site Status

Narayana Nethralaya

Bengaluru, , India

Site Status

The Eye Foundation

Coimbatore, , India

Site Status

Centre for Sight Eye Institute

New Delhi, , India

Site Status

All India Institute of Medical Sciences (AIIMS)

New Delhi, , India

Site Status

Oogziekenhuis Rotterdam

Rotterdam, , Netherlands

Site Status

ETZ

Tilburg, , Netherlands

Site Status

Kim's eye clinic

Seoul, , South Korea

Site Status

Korea Uni.Kuro

Seoul, , South Korea

Site Status

Clinica Oftalmologica Diez del Corral

Madrid, , Spain

Site Status

Mirzana IOA

Madrid, , Spain

Site Status

Vithas Alicante

Madrid, , Spain

Site Status

Countries

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New Zealand Australia Austria France Germany India Netherlands South Korea Spain

Other Identifiers

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PCOL204APME

Identifier Type: -

Identifier Source: org_study_id