The Condition of Fundus Neovascularization
Conditions
Brief summary
The goal of this prospective randomized controlled study is to compare the therapeutic effect of injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy at different time points. At present, studies have confirmed that anti-VEGF drugs are effective in inhibiting fundus neovascularization in proliferative diabetic retinopathy. The main question it aims to answer is which time point is better to injecting anti-VEGF drugs before surgery for patients with proliferative diabetic retinopathy. Participants will be randomly divided into three groups. And time points of injecting anti-VEGF drugs before surgery for each group will be 3 days, 7 days, 14 days. And we have a new technology that can have fluorescein fundus angiography during operation, so it can reflect the condition of fundus neovascularization immediately and precisely. In that case, we can compare the Inhibitory effect of anti-VEGF drugs on fundus neovascularization at different time points.
Interventions
OTHERTime
Time point of injecting anti-VEGF drugs
Sponsors
Jie Li
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and operating surgeons were not masked to the assigned surgical interval. Intraoperative fluorescein angiography recordings were anonymized and coded before assessment, and outcome assessors grading the images were masked to treatment allocation.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* PDR is diagnosed in people 18 years of age or older with type 1 or type 2 diabetes， * Hemoglobin A1c (HbA1c) ≤10% * Persistent vitreous hemorrhage for more than one month or recurrent vitreous hemorrhage (within six months) * Did not undergo retintis photocoagulation (PRP) * Vitreous hemorrhage disease course within six months
Exclusion criteria
* Patients who have had previous vitreoretinal surgery * Intravitreal drug injection within 3 months * Eye diseases other than PDR that may hinder vision improvement, such as optic atrophy or macular hole * Thromboembolic events (including cerebrovascular or myocardial infarction) or clotting system disorders or receiving anticoagulation or antiplatelet therapy * B-ultrasound or indirect fundus microscopy showing retina detachment (pull or hole origin) * Vitrectomy, FFA contraindicated patients, patients with severe abnormality of cardiopulmonary, liver and kidney function
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Active Retinal Neovascularization Tufts Assessed by Intraoperative Fluorescein Angiography | Intraoperatively, 1 to 3 minutes after fluorescein injection | Number of active retinal neovascularization tufts identified on intraoperative fluorescein angiography images. |
| Size of Active Retinal Neovascularization Assessed by Intraoperative Fluorescein Angiography | Intraoperatively, 1 to 3 minutes after fluorescein injection | Neovascularization size was quantified by measuring the maximal linear diameter and normalizing it to the vertical optic disc diameter, expressed in papillary diameters (PD). |
Countries
China
Outcome results
None listed