Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains
Launched by UNIVERSITAIRE ZIEKENHUIZEN KU LEUVEN · Aug 23, 2022
Trial Information
Current as of August 19, 2025
Completed
Keywords
ClinConnect Summary
To determine efficacy and safety of MONOBLUE DUAL View and MONOBLUE ILM View (study products) vital stains during vitrectomy surgery.
Both study products are CE-marked and legally marketed in Europe. The data collection will serve as Post-Marketing Clinical Follow-up according MDR provisions. Retrospective data will also be collected for the two reference products: ILM Blue® (DORC) and Membrane Blue Dual® (DORC) to serve as control. For this purpose, patient data will be used that were collected in studies S61408 (Comparative study 23G vs 27G vitrectomy), S63610 (Comparative study 27G vitr...
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- Adult patients who underwent for vitrectomy surgery where ILM and/or ERM removal is required:
- • Macular holes (ILM staining)
- • Macular pucker (ILM and ERM staining)
- • Vitreomacular traction (ILM staining)
- Exclusion Criteria:
- • Children aged \<18 years
- • Vitrectomy for other indication than mentioned in 3.1
- • Patients that have concomitant eye disease that may influence the outcome of the surgery, e.g. terminal glaucoma
- • Patients that did to comply to the postoperative examination visit 6-10 weeks after the surgery
About Universitaire Ziekenhuizen Ku Leuven
Universitaire Ziekenhuizen KU Leuven is a leading academic medical center in Belgium, renowned for its commitment to advancing healthcare through innovative research and clinical excellence. Affiliated with KU Leuven, one of Europe’s premier universities, the institution integrates cutting-edge scientific inquiry with high-quality patient care. It plays a pivotal role in the development and implementation of clinical trials, fostering collaboration between researchers, healthcare professionals, and industry partners to translate scientific discoveries into effective treatments. The hospital's multidisciplinary approach ensures comprehensive patient safety and ethical standards, positioning it as a trusted sponsor in the realm of clinical research.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Leuven, Vlaams Brabant, Belgium
Leuven, Vlaams Brabant, Belgium
Patients applied
Trial Officials
Peter Stalmans, Phd
Principal Investigator
UZ Leuven
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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