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

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

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Key information

Conditions

Cataracts Cataract Eye Diseases Lens Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Vision Eye Institute, Chatswood, New South Wales, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intervention

Device

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.

Primary outcomes

Visual Symptoms

Time frame: 3month postoperative

Patient questionnaires
Surgeon Experience

Time frame: 3month postoperative

Questionnaire
Visual Acuity

Time frame: 3month postoperative

Visual Acuity will be collected with standard clinical charts.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start: 2024
Primary completion: 2025
Study completion: 2025
First posted: Feb 9, 2024
Registry last updated: Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed