Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT06343961 |
| Other study ID # |
2024-76 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
April 18, 2024 |
| Est. completion date |
December 2025 |
Study information
| Verified date |
April 2024 |
| Source |
Sichuan Provincial People's Hospital |
| Contact |
Jie Zhong, doctor |
| Phone |
+86 13808063276 |
| Email |
676227997[@]qq.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The study used a new surgical technique: intraoperative fluorescence imaging,In the 1980s,
some scholars proposed the concept of intraoperative fluorescein angiography.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.
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 patient's 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.
