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| Name | Class |
|---|---|
| Cicendo Eye Hospital | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bevacizumab Intravitreal | Experimental | 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. |
|
| Control | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bevacizumab Injection [Avastin] | Drug | Intravitreal bevacizumab (1.25 mg/0.05 mL) was injected at the completion of vitrectomy surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1, 7, and 30 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Day 1, 7, and 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mohamad Eko Prayogo, MD | Faculty of Medicine Universitas Padjadjaran | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cicendo Eye Hospital | Bandung | Jawab Barat | 40117 | Indonesia |
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| ID | Term |
|---|---|
| D003930 | Diabetic Retinopathy |
| D014823 | Vitreous Hemorrhage |
| ID | Term |
|---|---|
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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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.
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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.
| Pars Plana Vitrectomy | Procedure | routine procedure of pars plana vitrectomy in vitreous hemorrhage for proliferative diabetic retinopathy patients |
|
| D002318 |
| Cardiovascular Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D005130 | Eye Hemorrhage |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |