Macular HolesNewBlueDyesNCT05517473
Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains
An observational study of Macular Holes and Macular Pucker, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Macular Holes, Macular Pucker, Vitreomacular Traction
- How many people
- 100 participants
- Where
- 1 siteBelgium
- Study dates
- 5 Jul 2022to 16 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: 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)
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains During Vitrectomy Surgery
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.
Read the detailed 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.
- Conditions
- Macular Holes, Macular Pucker, Vitreomacular Traction
- Medical subject headings
- Retinal Perforations, Epiretinal Membrane
What is being measured
The primary outcome is the main question the study is designed to answer.
visualization of membranes
visualization of membranes stained based on binary subjective evaluation.
Measured: intraoperative (surgery day)
Secondary outcomes (3)
surgical help
subjective assessment of surgical help provided by the product
Measured: intraoperative (surgery day)
adverse events
Rate and severity of potential study-related products adverse events
Measured: 1 day after surgery
visual acuity
Visual outcome at the last postoperative visit
Measured: 6 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start5 Jul 2022
- Primary completion16 Aug 2022
- Study completion16 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Macular HolesStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Stalmans, Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517473
- Sponsor's protocol ID
- S65841
- Acronym
- NewBlueDyes
- Status last verified
- Aug 2022
- First submitted
- 18 Aug 2022
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Evaluation of MONOBLUE DUAL View and MONOBLUE ILM View Vital Stains During Vitrectomy Surgery
- ClinicalTrials.gov ID
- NCT05517473
- Acronym / sponsor ID
- NewBlueDyes / S65841
- Conditions
- Macular Holes, Macular Pucker, Vitreomacular Traction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 5 Jul 2022 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Aug 2022 (actual)
- First posted
- 26 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 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)
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
visualization of membranes
Time frame: intraoperative (surgery day)
visualization of membranes stained based on binary subjective evaluation.
3 secondary outcomes
surgical help
Time frame: intraoperative (surgery day)
adverse events
Time frame: 1 day after surgery
visual acuity
Time frame: 6 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Stalmans, Phd principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Macular Holes and Macular Pucker, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
visualization of membranes (time frame: intraoperative (surgery day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022; AzTrials last refreshed its copy on 7 Nov 2026.