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

Recruiting

• Conditions: Cataracts

• Registration Number: NCT06250322
• Lead Sponsor: Johnson & Johnson Surgical Vision, Inc.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-02-01
• Study First Submitted QC: 2024-02-01
• Study First Posted: 2024-02-09
• Study Start: 2024-04-10
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-25
• Last Update Posted: 2025-04-27
• Primary Completion: 2025-06-02
• Study Completion: 2025-06-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Visual Symptoms	3month postoperative	Patient questionnaires
Surgeon Experience	3month postoperative	Questionnaire
Visual Acuity	3month postoperative	Visual Acuity will be collected with standard clinical charts.

Trial Locations

Locations (20)

Korea Uni.Kuro; 🇰🇷 Seoul, Korea, Republic of

Vision Eye Institute; 🇦🇺 Chatswood, New South Wales, Australia

Sunshine Eye Clinic; 🇦🇺 Birtinya, Queensland, Australia

The Queensland Eye Institute Foundation; 🇦🇺 Woolloongabba, Queensland, Australia

Lions Eye Institute; 🇦🇺 Nedlands, Western Australia, Australia

Narayana Nethralaya; 🇮🇳 Bangalore 560010, India

The Eye Foundation; 🇮🇳 Coimbatore 641002, India

All India Institute of Medical Sciences (AIIMS); 🇮🇳 New Delhi 110029, India

Centre for Sight Eye Institute; 🇮🇳 New Delhi, India

Vienna Institute for Research in Ocular Surgery - A Karl-Landsteiner-Institute; 🇦🇹 Vienna, Austria

CHU Morvan Brest; 🇫🇷 Brest, France

Clinique Juge Marseille; 🇫🇷 Marseille, France

Augenklinik Ahaus GmbH & Co. KG; 🇩🇪 Ahaus, Germany

Augenklinik Dardenne; 🇩🇪 Bonn, Germany

Kim's eye clinic; 🇰🇷 Seoul, Korea, Republic of

Oogziekenhuis Rotterdam; 🇳🇱 Rotterdam, Netherlands

ETZ; 🇳🇱 Tilburg, Netherlands

Clinica Oftalmologica Diez del Corral; 🇪🇸 Madrid, Spain

Mirzana IOA; 🇪🇸 Madrid, Spain

Vithas Alicante; 🇪🇸 Madrid, Spain