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

• Sponsor: Johnson & Johnson Surgical Vision, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05394324
• Collaborator: (none)
• Enrollment: 3,000
• Location: 1
• Anticipated Duration (Months): 35.3
• Patients Per Site Per Month: 84.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Refractive Error; Glaucoma; Cataracts	Device: Intervention

Study Design

• Study Type: Observational
• Anticipated Enrollment: 3000 participants
• Observational Model: Cohort
• Time Perspective: Retrospective
• Official Title: A Post-market Clinical Study to Collect Safety and Performance Data on Johnson & Johnson Surgical Vision Products
• Actual Study Start Date: Jun 21, 2022
• Anticipated Primary Completion Date: May 31, 2025
• Anticipated Study Completion Date: May 31, 2025

Outcome Measures

Primary Outcome Measures

1. Incidence of Adverse Events [up to 12-months post-operation]

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

2. BCDVA [up to 12-months post-operation]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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 week 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 (0.66 decimal, 6/9 or 20/30 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Empire Eye and Laser Center	Bakersfield	California	United States	93309

Sponsors and Collaborators

• Johnson & Johnson Surgical Vision, Inc.

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Johnson & Johnson Surgical Vision, Inc.
• ClinicalTrials.gov Identifier: NCT05394324
• Other Study ID Numbers: JJSV301PMCF
• First Posted: May 27, 2022
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• 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
• Additional relevant MeSH terms: Cataract; Refractive Errors

Study Results

No Results Posted as of Aug 9, 2022