CompletedNot Applicable

IVB for Post-vitrectomy Hemorrhage in Diabetic Eyes

Indonesia18 participantsStarted 2018-04-02

Plain-language 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 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Incidence and Severity of Vitreal Hemorrhage Post-Operative

Timeframe: Day 1, 7, and 30

Trial details

NCT IDNCT06559488

SponsorUniversitas Padjadjaran

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-31

View on ClinicalTrials.gov More Diabetic Retinopathy trials