Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343961
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-11
Brief Title:
Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy
Sponsor:
Jie Zhong
Organization:
Sichuan Provincial Peoples Hospital
Study Overview
Official Title:
To Evaluate the Value of Vitrectomy Combined With Sodium Fluorescein Angiography in the Diagnosis and Treatment of Vascular Retinal Diseases
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study used a new surgical technique intraoperative fluorescence imagingIn the 1980s some scholars proposed the concept of intraoperative fluorescein angiographyDuring vitrectomy intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapyThrough this technology the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery providing effective imaging evidence support for the design of further treatment
Detailed Description:
With the improvement of living standards the aging of population the increasing incidence of chronic diseases such as hypertension and diabetes in China the incidence of vascular retinopathy retinal vein obstruction diabetic retinopathy retinal vasculitis etc has also shown an increasing trend and has become an important cause of blindness Clinically retinal angiofluciferin sodium angiography is mainly used to diagnose the cause of the disease This technique has been widely used in clinic for more than 30 years and it is safe and effective However its disadvantage is that patients need to have good refractive media and the morphological changes of retinal blood vessels can be clearly observed Vitreous hemorrhage is the most common complication of vascular retinal disease which can be treated by vitrectomy However the occlusion of preoperative blood accumulation makes it impossible to effectively implement fluorescein sodium angiography which makes doctors unable to make a comprehensive judgment of the disease in advance which may affect the treatment plan and thus the therapeutic effect Therefore it is particularly important to comprehensively evaluate the primary disease of the patients retina after removing the hematoma during the operation
In the 1980s some scholars proposed the concept of intraoperative fluorescein angiography but due to poor camera resolution insufficient digital image quality and transmission delay the application of this technology in the surgical process is limited In recent years the rapid development of digitally assisted vitrectomy has enabled fundus surgeons to perform vitrectomy with a high-definition 3D screen This technique also enables full visualization of intraoperative angiography that has not been possible before and further real-time surgery based on this information During vitrectomy intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy Through this technology the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery providing effective imaging evidence support for the design of further treatment In this study a specific light source and filter were designed according to Zeiss intraoperative microscope Combined with 3D microscope the morphology and function of retinal blood vessels can be effectively observed during the operation which has not been reported in China Using this technology the team successfully observed clinical features such as non-perfusion area neovascularization and early formation of laser spots during vitrectomy thus contributing to accurate treatment of the disease
In the 1980s some scholars proposed the concept of intraoperative fluorescein angiography but due to poor camera resolution insufficient digital image quality and transmission delay the application of this technology in the surgical process is limited In recent years the rapid development of digitally assisted vitrectomy has enabled fundus surgeons to perform vitrectomy with a high-definition 3D screen This technique also enables full visualization of intraoperative angiography that has not been possible before and further real-time surgery based on this information During vitrectomy intraoperative fluorescein angiography under 3D microscope can guide the surgeon to observe the non-perfusion area and new blood vessels on the same screen for accurate retinal photocoagulation therapy Through this technology the primary retinal disease can be identified in time after the removal of vitreous hemorrhage during surgery providing effective imaging evidence support for the design of further treatment In this study a specific light source and filter were designed according to Zeiss intraoperative microscope Combined with 3D microscope the morphology and function of retinal blood vessels can be effectively observed during the operation which has not been reported in China Using this technology the team successfully observed clinical features such as non-perfusion area neovascularization and early formation of laser spots during vitrectomy thus contributing to accurate treatment of the disease
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None