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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Glaucoma; Refractive Error; Cataracts; Clear Lens Exchange
• Intervention / Treatment: Device: Intervention

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

Study Locations

• Germany
  • Berlin, Germany, 10559
    • Augentagesklinik Spreebogen Berlin GbR
  • Nordrhein-Westfalen
    • Ahaus, Nordrhein-Westfalen, Germany, 48683
      • Augenaerzte Gerl & Kollegen MVZ Ahaus GmbH
  • SN
    • Zschopau, SN, Germany, 09405
      • Augenzentrum Erzgebirge
• Spain
  • Madrid, Spain, 28008
    • Clinica Oftalvist
  • Alacant
    • Alicante, Alacant, Spain, 03015
      • Clinica Vistahermosa
  • Andalusia
    • Cordoba, Andalusia, Spain, 14012
      • Hospital La Arruzafa
  • CL
    • Valladolid, CL, Spain, 47011
      • Instituto Universitario de Oftalmobiologia Aplicada
  • CT
    • Barcelona, CT, Spain, 08025
      • Hosp. de La Santa Creu I Sant Pau
  • MD
    • Madrid, MD, Spain, 28040
      • Hospital Clinico San Carlos
• United States
  • Alabama
    • Dothan, Alabama, United States, 36301
      • Trinity Research Group, LLC
  • California
    • Bakersfield, California, United States, 93309
      • Empire Eye and Laser Center
  • Minnesota
    • Bloomington, Minnesota, United States, 55420
      • Chu Vision Institute
  • Texas
    • McAllen, Texas, United States, 78503
      • Valley Retina Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who have been implanted with and/or have undergone ophthalmic surgery using commercial JJSV product(s).

Description

Inclusion Criteria:

1. Patients who have been implanted with and/or undergone ophthalmic surgery using targeted JJSV products
2. 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:

1. Concurrent participation (during the retrospective follow-up period) in an interventional (drug, device, biologic, etc.) clinical trial
2. Use of surgical devices not in accordance with the product labeling or indications for use
3. 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
4. Use of systemic or ocular medications that may affect vision during the retrospective data collection period
5. Known ocular disease or pathology that, in the opinion of the investigator may confound study findings during the retrospective data collection period
6. Pregnancy, lactating, or other condition associated with hormonal fluctuation that could lead to refractive changes during the retrospective data collection period.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	incidence of adverse events that are specified in the ISO 11979-7 Safety and Performance Endpoints.	up to 12 months post-operation
BCDVA	The proportion of eyes achieving 20/40 or better BCDVA.	up to 12 months post-operation

Collaborators and Investigators

• Sponsor: Johnson & Johnson Surgical Vision, Inc.
• Investigators: Study Director: Johnson & Johnson Surgical Vision, Inc. Clinical Trial, Johnson & Johnson Surgical Vision, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 21, 2022
• Primary Completion (Estimated): May 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: May 24, 2022
• First Submitted That Met QC Criteria: May 24, 2022
• First Posted (Actual): May 27, 2022

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 25, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Refractive Errors; Cataract
• Other Study ID Numbers: JJSV301PMCF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Johnson & Johnson Medical Device Companies have an agreement with the Yale Open Data Access (YODA) to serve as the independent review panel for evaluation of requests for clinical study reports and participant level data from investigators and physicians for scientific research that will advance medical knowledge and public health. Requests for access to the study data can be submitted through the YODA Project site at http://yoda.yale.edu

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes