Skip to main content
OpenTrials
Completed

NCT Number: NCT05394324

A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products

Retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH, Ahaus, North Rhine-Westphalia, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
  • Status post ophthalmic surgery between 1 day and 24 months for Year 1. Subsequent years after Year 1 will be between 1 day and 18 months.

Exclusion criteria

  • Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
  • Use of surgical devices not in accordance with the product labeling or indications for use
  • Degenerative visual disorders (e.g., macular degeneration or other retinal disorders) that cause visual acuity losses to a level worse than 0.2 logMAR (0.63 decimal, 6/9.5 or 20/32 Snellen) during the retrospective data collection period
  • Use of systemic or ocular medications that may affect vision during the retrospective data collection period
  • Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
  • Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Treatment and study plan

Intervention

Device

No study treatments will be administered during this retrospective study. However, data will be collected from medical records of patients who have been treated with subject devices of this study.

Primary outcomes

  1. Incidence of Adverse Events

    Time frame: up to 12 months post-operation

    incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.

  2. BCDVA

    Time frame: up to 12 months post-operation

    The proportion of eyes achieving 20/40 or better BCDVA.

Sponsors and collaborators

Lead sponsor

Johnson & Johnson Surgical Vision, Inc.

Industry

Registry information

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
May 27, 2022
Registry last updated
Jul 20, 2025

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.