IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

Universitas Padjadjaran18 enrolled

Overview

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant complication with reported incidence ranging from 11 to 75%. Early and late recurrences are associated with various factors, including residual blood, fibrovascular tissue, and neovascularization. Despite attempts to reduce this complication with therapies like anti-fibrinolytic agents, gas tamponade, and peripheral cryotherapy, the outcomes remain unsatisfactory.

Recurrent vitreous hemorrhage following pars plana vitrectomy (PPV) for proliferative diabetic retinopathy remains a significant challenge with high incidence and negative impact on visual outcomes. Despite various treatments, intravitreal bevacizumab (IVB) has shown potential in reducing post-operative vitreous hemorrhage (PO-VH). This study aims to determine the efficacy and safety of intraoperative IVB in preventing PO-VH in patients undergoing vitrectomy for diabetic vitreous hemorrhage. This prospective, randomized controlled trial compared patients receiving intraoperative IVB to a control group. The primary outcome was PO-VH incidence at one month, with secondary outcomes including visual acuity change, time to VH clearance, and safety. Outcome assessors were masked to the study treatment. Data on demographics, medical history, visual acuity, VH grading, intraoperative findings, and postoperative complications will be collected. Statistical analysis compared PO-VH incidence and other outcomes between groups. This study will provide valuable evidence on the efficacy and safety of intraoperative IVB in preventing PO-VH, contributing to improved clinical practice and patient outcomes.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Diabetic Retinopathy Vitreous Hemorrhage

Interventions

Bevacizumab Injection [Avastin]DRUG

Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery.

Pars Plana VitrectomyPROCEDURE

routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy. Exclusion Criteria: * Patients with tractional retinal detachment (ART) * Patients with severe fibrovascular traction, * Patients with intravitreal gas or silicone oil tamponade at the end of surgery * Patients with other eye diseases besides diabetic vitreous hemorrhage * Patients with history of intravitreal bevacizumab injection in the last 3 months before surgery * Patients with other health condition includes uncontrolled hypertension, a history of coagulopathy * Patients with inability to attend follow-up examinations for at least 1 month * Patients taking anti-aggregation and anti-platelet medications with abnormal bleeding time (BT) and clotting time (CT)

Locations (1)

Cicendo Eye Hospital

Bandung, Jawab Barat, Indonesia

Outcomes

Primary Outcomes

Incidence and Severity of Vitreal Hemorrhage Post-Operative

Calculation of incidence of Vitreal Hemorrhage Post Operative based on grading (Grade 0, Grade 1, Grade 2, Grade 3, Grade 4) between two groups; higher grades are related to worse outcomes

Time frame: Day 1, 7, and 30

Secondary Outcomes

Post operative visual Acuity, compared between groups

Visual acuity measured with a Snellen chart was converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis. Snellen visual acuity of finger counting was categorized as log MAR 2.0, and hand motion as log MAR 3.0

Time frame: Day 1, 7, and 30

Data from ClinicalTrials.gov

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