Status:
COMPLETED
IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes
Lead Sponsor:
Universitas Padjadjaran
Collaborating Sponsors:
Cicendo Eye Hospital
Conditions:
Diabetic Retinopathy
Vitreous Hemorrhage
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ...
Detailed Description
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. D...
Eligibility Criteria
Inclusion
- Patients with spontaneous, non-clearing vitreous hemorrhage for at least one month as the initial vitrectomy indication for diabetic retinopathy.
Exclusion
- 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)
Key Trial Info
Start Date :
April 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2019
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06559488
Start Date
April 2 2018
End Date
March 31 2019
Last Update
August 27 2024
Active Locations (1)
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1
Cicendo Eye Hospital
Bandung, Jawab Barat, Indonesia, 40117