Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy

NCT06343961 | Not Yet Recruiting

• 1 other identifier: 2024-76
• Study Type: interventional
• Target: 80
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Vascular Retinopathy of Left Eye (Disorder); Vascular Retinopathy of Right Eye (Disorder); Diabetic Retinopathy; Retinal Vein Occlusion; Retinal Vasculitis; Vitreous Hemorrhage

Keywords

Intraoperative fluoroscopy; Fluorescein Angiography; laser; targeted retinal photocoagulation; retinal vascular disease

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

targeted retinal photocoagulation(TRP)

EXPERIMENTAL

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

panretinal photocoagulation(PRP)

EXPERIMENTAL

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

Interventions

Intraoperative Fluorescein Angiography PROCEDURE

Targeted laser photocoagulation under the guidance of intraoperative fluoroscopy

panretinal photocoagulation(PRP); targeted retinal photocoagulation(TRP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Jie Zhong: lead

MeSH Terms

Conditions

Diabetic Retinopathy; Retinal Vein Occlusion; Retinal Vasculitis; Vitreous Hemorrhage

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vasculitis; Eye Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Jie Zhong, doctor

CONTACT

+86 13808063276; 676227997@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: A total of 80 patients with vitreous hemorrhage diagnosed in Sichuan Provincial People's Hospital from January 2024 to December 2025 were selected. The number of included cases was calculated according to the minimum sample size of 200 patients with vitreous hemorrhage in our hospital, 95% confidence level and 5% confidence interval, and the calculated result was 79. The included cases were equally divided by random number method. 40 patients in the control group were given vitrectomy and other conventional operations such as retinal laser photocoagulation. In contrast group, 40 patients were given vitrectomy combined with intraoperative fluorescein angiography and other conventional operations such as retinal laser photocoagulation. The diagnosis rate of primary disease cause, observation rate of neovascularization and non-perfusion area, visual acuity, visual field, thickness of macular fovea and postoperative complications (ciliary detachment, secondary vitreous hemorrhage, neovascu

Study Record Dates

• First Submitted: March 11, 2024
• First Posted: April 3, 2024
• Study Start: April 18, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: April 3, 2024

Record last verified: 2024-04