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NCT06250322 Clinical Trial

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

Cataracts Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06250322
Other study ID # PCOL204APME
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date April 10, 2024
Est. completion date March 1, 2025

Study information
Verified date April 2024
Source Johnson & Johnson Surgical Vision, Inc.
Contact Study Contact
Phone +49 170 7804891
Email mfaust@its.jnj.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 300
Est. completion date March 1, 2025
Est. primary completion date December 31, 2024
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• 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.

Locations
Country Name City State
Austria Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute Vienna
France CHU Morvan Brest Brest
France Clinique Juge Marseille Marseille
Germany Augenklinik Ahaus GmbH & Co. KG Ahaus
Germany Augenklinik Dardenne Bonn
Korea, Republic of Kim's eye clinic Seoul
Korea, Republic of Korea Uni.Kuro Seoul
Netherlands Oogziekenhuis Rotterdam Rotterdam
Netherlands ETZ Tilburg
Spain Clinica Oftalmologica Diez del Corral Madrid
Spain Mirzana IOA Madrid
Spain Vithas Alicante Madrid

Sponsors (1)
Lead Sponsor Collaborator
Johnson & Johnson Surgical Vision, Inc.

Countries where clinical trial is conducted

Austria,  France,  Germany,  Korea, Republic of,  Netherlands,  Spain, 

Outcome
Type Measure Description Time frame Safety issue
Primary Visual Symptoms Patient questionnaires 3month postoperative
Primary Surgeon Experience Questionnaire 3month postoperative
Primary Visual Acuity Visual Acuity will be collected with standard clinical charts. 3month postoperative
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