Vascular Retinopathy of Left Eye (Disorder)NCT06343961
Intraoperative Application of Fluorescein Sodium Angiography in Vascular Retinopathy
A study testing Intraoperative Fluorescein Angiography in people with Vascular Retinopathy of Left Eye (Disorder) and Vascular Retinopathy of Right Eye (Disorder), run by Jie Zhong.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Retinopathy of Left Eye (Disorder), Vascular Retinopathy of Right Eye (Disorder), Diabetic Retinopathy
- What is being tested?
- Intraoperative Fluorescein Angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 18 Apr 2024to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Vascular Retinopathy of Left Eye (Disorder), Vascular Retinopathy of Right Eye (Disorder), Diabetic Retinopathy, Retinal Vein Occlusion, Retinal Vasculitis, Vitreous Hemorrhage
- Being tested
- Intraoperative Fluorescein Angiography
- Keywords
- Intraoperative fluoroscopy, Fluorescein Angiography, laser, targeted retinal photocoagulation, retinal vascular disease
- Medical subject headings
- Diabetic Retinopathy, Retinal Vein Occlusion, Retinal Vasculitis, Vitreous Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoperative Fluorescein AngiographyProcedure or surgery
Targeted laser photocoagulation under the guidance of intraoperative fluoroscopy
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 . Receives: Procedure: Intraoperative Fluorescein Angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
best corrected visual acuity
The best corrected visual acuity of patients at 1 week, 1 month, 3 months and 6 months after surgery
Measured: 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
Measured: 1 week, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start18 Apr 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vascular Retinopathy of Left Eye (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jie Zhong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Jie Zhong, Sichuan Provincial People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06343961
- Sponsor's protocol ID
- 2024-76
- Status last verified
- Apr 2024
- First submitted
- 11 Mar 2024
- Last updated
- 3 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Evaluate the Value of Vitrectomy Combined With Sodium Fluorescein Angiography in the Diagnosis and Treatment of Vascular Retinal Diseases
- ClinicalTrials.gov ID
- NCT06343961
- Acronym / sponsor ID
- 2024-76
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Jie ZhongUniversity, hospital or other
- Study start
- 18 Apr 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 3 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| targeted retinal photocoagulation(TRP) | Experimental | Procedure: Intraoperative Fluorescein AngiographyTRP 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. |
| panretinal photocoagulation(PRP) | Experimental | Procedure: Intraoperative Fluorescein AngiographyThe 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 . |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intraoperative Fluorescein AngiographyTargeted laser photocoagulation under the guidance of intraoperative fluoroscopy | Procedure or surgery | panretinal photocoagulation(PRP), targeted retinal photocoagulation(TRP) |
Primary outcome
best corrected visual acuity
Time frame: 1 week, 1 month, 3 months, 6 months
The best corrected visual acuity of patients at 1 week, 1 month, 3 months and 6 months after surgery
Central retinal thickness
Time frame: 1 week, 1 month, 3 months, 6 months
Central retinal thickness at 1 week, 1 month, 3 months, and 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoperative Fluorescein Angiography in people with Vascular Retinopathy of Left Eye (Disorder) and Vascular Retinopathy of Right Eye (Disorder), run by Jie Zhong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jie Zhong, doctor (+86 13808063276, 676227997@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
best corrected visual acuity (time frame: 1 week, 1 month, 3 months, 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2024.