Post-market study to collect safety & performance data: JJSV products
Research type
Research Study
Full title
A post-market clinical study to collect safety and performance data on Johnson & Johnson Surgical Vision products.
IRAS ID
327514
Contact name
Michael Faust
Contact email
Sponsor organisation
Johnson & Johnson Surgical Vision
Clinicaltrials.gov Identifier
272713, Parexel Ref
Duration of Study in the UK
2 years, 1 months, 30 days
Research summary
This is a non-interventional, retrospective study.
There will be no study-required treatment, visits or procedures, and patients will be treated according to the sites normal practice.
In this study, operative and postoperative clinical data will be collected from medical records of patients who have undergone ophthalmic surgery and/or been implanted and/or used JJSV products. Collected data will be analyzed by product category and/or model and compared to ISO Safety and Performance Endpoint (SPE) rates as part of the post-market clinical follow-up requirements for CE mark under the European Medical Device Regulation.
The study will run across 40 sites worldwide with data from up to approximately 1000 cases collected per year with total duration of 3 years.REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
23/EM/0196
Date of REC Opinion
6 Sep 2023
REC opinion
Favourable Opinion