Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains

Macular Holes Clinical Trial

— NewBlueDyes  

Official title:

Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains During Vitrectomy Surgery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517473
• Other study ID #: S65841
• Status: Completed
• Start date: July 5, 2022
• Est. completion date: August 16, 2022

Study information

• Verified date: August 2022
• Source: Universitaire Ziekenhuizen Leuven
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study, the investigators aim to collect data regarding the efficiency and safety of two dyes used intraoperatively in vitrectomy to stain intraocular tissues. These products have the necessary approvals to use during such operation,These are NOT experimental products.

Description:

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 vitrectomy vs larger gauge surgery) and S64913 (EVA Nexus Field Observation Study).

The expected effect of the study products is to provide the retinal surgeon with adequate aid in visualizing the membranes involved in the retinal pathology to treat, thanks to their staining capabilities.

The performance of the study products is related to the visualization of retinal tissues (ILM and/or ERM) during the vitrectomy procedure, when these tissues cannot be distinguished accurately enough without staining. Their use allows for better identification of these tissues and facilitates their removal by the surgeon. The clinical benefit of using ophthalmic dyes is to increase the patient's ability to recover anatomically and functionally by allowing more precise surgery with an effective visualization tool.

Along with collecting post-marketing clinical follow-up data on the subject products, the outcomes of the present study results may be used at the UZLeuven Hospital to decide to use Monoblue ILM View and/or Monoblue Dual View as standard-of-care, replacing Membrane Blue Dual and ILM Blue.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Macular Holes
• Macular Pucker
• Retinal Perforations
• Vitreomacular Traction

Locations

Country	Name	City	State
Belgium	UZ Leuven	Leuven	Vlaams Brabant

Sponsors (1)

Lead Sponsor	Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	visualization of membranes	visualization of membranes stained based on binary subjective evaluation.	intraoperative (surgery day)
Secondary	surgical help	subjective assessment of surgical help provided by the product	intraoperative (surgery day)
Secondary	adverse events	Rate and severity of potential study-related products adverse events	1 day after surgery
Secondary	visual acuity	Visual outcome at the last postoperative visit	6 weeks after surgery