Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy

To Evaluate the Value of Vitrectomy Combined With Sodium Fluorescein Angiography in the Diagnosis and Treatment of Vascular Retinal Diseases

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Diabetic Retinopathy; Retinal Vein Occlusion; Vitreous Hemorrhage; Retinal Vasculitis; Vascular Retinopathy of Left Eye (Disorder); Vascular Retinopathy of Right Eye (Disorder)
• Intervention / Treatment: Procedure: Intraoperative Fluorescein Angiography

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 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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jie Zhong, doctor; Phone Number: +86 13808063276; Email: 676227997@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• There is non-absorption vitreous hemorrhage in the target eye, which requires vitrectomy;
• can follow up according to the time specified by the study;
• Age ≥ 18 years old;
• Accurate Humphrey visual field test can be performed after surgery;
• Post-operative pupil dilation and clear media for laser photocoagulation, digital photography, and OCT scanning;

Exclusion Criteria:

• Active eyelid or accessory infection;
• Medical, surgical, panomental laser, or macular laser treatment of the study eye in the past 12 months;
• Brain disease, systemic immune system disease and other related medical history;
• Preoperative blood pressure (blood pressure greater than or equal to 180/110 mmHg), blood glucose (recent (past 6 months) or ongoing poor diabetes control, ·glycated hemoglobin > 10.0 mg/dl) poor control;
• Patients with choroidal detachment and ciliary detachment before surgery;
• Any systemic drug known to be toxic to the retina or associated with the risk of macular edema;Any prior eye conditions associated with the risk of macular edema;
• History of food and drug allergy;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: targeted retinal photocoagulation(TRP); TRP is a laser technology aimed at the peripheral non-perfusion and ischemic areas of the retina, and the laser area is determined according to the degree and progression ofthe patient's retinopathy.TRP can specifically act on unperfused retinal capillaries and retinal intermediate ischemic areas, reduce damage to tissue perfusion areas and panretinal photocoagulation (PRP) complications or adverse events.	Procedure: Intraoperative Fluorescein Angiography; Targeted laser photocoagulation under the guidance of intraoperative fluoroscopy
Experimental: panretinal photocoagulation(PRP); The scope oftraditional PRP is mainly distributed in the middle and peripheral part of the retina, 1.5-2 optic disc diameters (DD) posteriorly from the optic disc and 2 DD temporally from the fovea,bounded by the superior and inferior vascular arches; forward to the ampulla of the vortex vein (or equator). Currently, PRP is the gold standard for the treatment of extensive areas of non-perfusion , as well as the main method for the treatment of severe nonproliferative diabetic retinopathy (NPDR) and PDR. However, due to the photochemical damage of the laser,panretinal laser photocoagulation causes more damage to the ocular tissue, and its side effects include hemorrhage, choroidal detachment, acute angle-closure glaucoma, etc. The occurrence of these complications is closely related to laser parameters such as increased duration and power and intensive treatment in a single session, which all lead to increased diffusion of thermal energy within the retina and choroid .	Procedure: Intraoperative Fluorescein Angiography; Targeted laser photocoagulation under the guidance of intraoperative fluoroscopy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
best corrected visual acuity	The best corrected visual acuity of patients at 1 week, 1 month, 3 months and 6 months after surgery	1 week, 1 month, 3 months, 6 months
Central retinal thickness	Central retinal thickness at 1 week, 1 month, 3 months, and 6 months after surgery	1 week, 1 month, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Jie Zhong

Study record dates

Study Major Dates

• Study Start (Estimated): April 18, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 11, 2024
• First Submitted That Met QC Criteria: April 2, 2024
• First Posted (Actual): April 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 3, 2024
• Last Update Submitted That Met QC Criteria: April 2, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: laser; Fluorescein Angiography; retinal vascular disease; Intraoperative fluoroscopy; targeted retinal photocoagulation
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Endocrine System Diseases; Diabetic Angiopathies; Diabetes Complications; Diabetes Mellitus; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Eye Hemorrhage; Retinal Diseases; Diabetic Retinopathy; Retinal Vein Occlusion; Hemorrhage; Vasculitis; Retinal Vasculitis; Vitreous Hemorrhage
• Other Study ID Numbers: 2024-76

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No