MULTICENTER, OBSERVATIONAL, SINGLE ARM STUDY OF THE TECNIS PRESBYOPIA-CORRECTING INTRAOCULAR LENS

Johnson & Johnson Surgical Vision, Inc.4 sites in 1 country300 target enrollmentStarted: April 15, 2025Last updated: November 13, 2025

Trial Snapshot

Phase: Unknown
Status: Completed
Sponsor: Johnson & Johnson Surgical Vision, Inc.
Enrollment: 300
Locations: 4
Primary Endpoint: 1. Patient questionnaires for visual symptoms and satisfaction

Study Overview Study Design Eligibility Criteria Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief Summary

The intraocular lenses (IOL) tested in this study, TECNIS PureSee non-toric (model DEN00V) and/or Toric II IOL (models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600), are an EDOF IOL with extended depth of focus that provides good distance vision as well as improved intermediate and near vision compared to a standard monofocal IOL. The study is an observational study of patients’ and surgeons’ experiences with the TECNIS PureSeeâ„¢ IOL. The lack of a control arm is justified as it is a non-comparative evaluation of a CE-marked product with a focus on collecting data on surgeons’ and patients’ experiences with the product.

Post-market data on visual symptoms, patient satisfaction and surgeon experience with the TECNIS PureSeeTM IOL will be collected within the clinical observational study.

Multicenter, single-arm, bilateral clinical observational study. A total of approximately 300 patients will be included, who will be called in once for a prospective postoperative follow-up examination 3 months after bilateral implantation. The preoperative and operative data will be collected retrospectively after inclusion of the patients.

Measures and procedure: After informed consent of the patient and examination of the inclusion and exclusion criteria, each patient will be called in once for a prospective postoperative follow-up examination 3 months (45 -90 days) after surgery of the 2nd eye. During this postoperative visit, visual acuity is measured at distance, intermediate and near. Data on visual symptoms and patient satisfaction are collected. In addition, the binocular measurement of the defocus curve is carried out if necessary. The preliminary examination and the operations on both eyes are not part of the study. The data routinely collected by each study center will be collected retrospectively from the patient’s file after the patient’s consent, and after the single postoperative follow-up examination has been performed for all patients per study center, the surgeons involved per study center will be asked to complete a questionnaire on their experiences with the IOL.

The study will be conducted in EMAE and APAC.

10 EMEA site are included in Germany (2), Netherlands (2), Spain (3), Austria (1), France (2). The study was already approved in all countries included. 4 Sites have been activated, 3 site have started recruitment.

10 APAC sites are planned: Australia (4), Korea (2), India (4)

Study Design

Study Type: Observational

Eligibility Criteria

Ages: 18.00 Year(s) to 80.00 Year(s) (—)
Sex: All

Inclusion Criteria

•Patients who are bilaterally implanted with TECNIS PureSee IOL following cataract extraction and are at least 45 days postoperative from their second eye surgery at the time of the study visit:.
•Eyes may be implanted with any combination of TECNIS PureSee non-toric (Model DEN00V) and/or Toric II IOL (Models DET100, DET150, DET225, DET300, DET375, DET450, DET525 and DET600);.
•Patients with or without prior corneal refractive surgery;.
•Clear intraocular media;.
•Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to study procedures in the governing countries;.
•Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures; â€¢ 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 and/or surgical complications that might impact outcomes during the study visit as determined by the investigator;
•Use of systemic or ocular medication that may affect vision;
•Acute or chronic disease or condition, ocular trauma or surgery that may confound results (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.);
•Patients with amblyopia, strabismus, nystagmus;
•Concurrent participation in another clinical trial.