IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-04-02

Study Completion Date

2019-03-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Diabetic Retinopathy Vitreous Hemorrhage

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

A parallel group design was employed. Patients requiring vitrectomy for diabetic non-clearing vitreous hemorrhage (VH) were divided into two groups:

Intervention Group: Underwent vitrectomy followed by an intravitreal injection of bevacizumab (1.25 mg/0.05 mL).

Control Group: Underwent vitrectomy alone.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

While it was not possible to mask participants and surgeons to the treatment allocation due to the nature of the surgical intervention, efforts were made to mask the outcome assessors. This involved:

Centralized Data Collection: All data related to patient outcomes (visual acuity, VH grading, complications) were collected on standardized forms and sent to a central data management center.

Coded Data Entry: Patient identification numbers were used instead of names to prevent bias.

Masked Data Analysis: The statistician conducting the analysis was blinded to group allocation.

Study Groups

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Bevacizumab Intravitreal

Ten patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed. Post-vitrectomy, 1.25 mg bevacizumab injected via 30-gauge needle in superotemporal or inferotemporal pars plana.

Group Type EXPERIMENTAL

Bevacizumab Injection [Avastin]

Intervention Type DRUG

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

Pars Plana Vitrectomy

Intervention Type PROCEDURE

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

Control

Eight patients underwent pars plana vitrectomy under local anesthesia. Vitrectomy used 3 23-gauge sclerotomies, triamcinolone for hyaloid cleaning, and hemostasis by elevated pressure, endo-diathermy, or laser. Panretinal laser applied to unlasered retina. Retina examined for tears or bleeding. IOP set at 20mmHg, sclerotomies sutured if needed.

Group Type EXPERIMENTAL

Pars Plana Vitrectomy

Intervention Type PROCEDURE

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

Interventions

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Bevacizumab Injection [Avastin]

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

Intervention Type DRUG

Pars Plana Vitrectomy

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

Intervention Type PROCEDURE

Other Intervention Names

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Pars Plana Vitrectomy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No