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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05394324
• Other study ID #: JJSV301PMCF
• Status: Enrolling by invitation
• Start date: June 21, 2022
• Est. completion date: May 31, 2025

Study information

• Verified date: June 2024
• Source: Johnson & Johnson Surgical Vision, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 3000
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cataract
• Cataracts
• Glaucoma
• Refractive Error
• Refractive Errors

Intervention

Device:
• Intervention
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Johnson & Johnson Surgical Vision, Inc.

Countries where clinical trial is conducted

United States,  Germany,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	BCDVA	The proportion of eyes achieving 20/40 or better BCDVA.	up to 12 months post-operation