Macular Holes Clinical Trial
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.
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. ;
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT03713268 -
Intraoperative OCT Guidance of Intraocular Surgery II
|
||
Completed |
NCT04535622 -
Efficacy of Exercise Program for Facedown Posture-related Pain After Retinal Surgery
|
N/A | |
Completed |
NCT03572725 -
Air Tamponade and Non-supine Positioning in Macular Hole Surgery.
|
N/A | |
Completed |
NCT01471912 -
Elongation of Foveal Tissue After Macular Hole Surgery
|
N/A | |
Completed |
NCT03646695 -
ILM Flap Transposition Versus ILM Peeling for Macular Holes: a Pilot Study
|
N/A | |
Completed |
NCT06323902 -
Autologous Platelet-rich Plasma as a Treatment for Macular Holes
|
||
Completed |
NCT01974310 -
Postoperative Positioning After Surgery for Macular Holes
|
N/A | |
Completed |
NCT00537992 -
Blue-Blocking IOLs in Combined Surgery
|
N/A | |
Completed |
NCT05171621 -
Measuring Subjective Quality of Vision and Metamorphopsia Before and After Epiretinal Membrane and Macular Hole Surgery
|
||
Recruiting |
NCT06000111 -
Duration of Face Down Positioning for Full-Thickness Macular Hole Repair
|
N/A | |
Recruiting |
NCT04135638 -
Inverted ILM-flap Techniques Variants for Macular Hole Surgery: Outcomes Comparison
|
N/A | |
Completed |
NCT03525899 -
Macular Hole After Diabetic Vitrectomy
|
||
Completed |
NCT03917602 -
Human Amniotic Membrane Plug for Large Macular Holes
|
N/A | |
Completed |
NCT04527848 -
Comparison of Two Intraocular Gas Injection Techniques in Macula Hole Surgery
|
Phase 4 | |
Recruiting |
NCT04116892 -
Comparative Analysis of Large Macular Hole Surgeries
|
N/A | |
Completed |
NCT01229657 -
Evaluation of Anatomic and Visual Outcomes of Initially Closed Macular Holes
|
N/A | |
Completed |
NCT01306487 -
Observation of Recovery of Foveal Cone Microstructures After Macular Hole Surgery
|
N/A | |
Completed |
NCT01381965 -
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
|
N/A | |
Completed |
NCT03174639 -
High Myopia Macular Hole and Retinal Detachment Treated With Double ILM Flaps
|
N/A | |
Recruiting |
NCT05083650 -
Large Macular Hole Closure Rate With Amniotic Membrane Graft With and Without Limitorrhexis
|
N/A |