To evaluate the safety and efficacy of fibrin glue in preventing early recurrence of vitreous haemorrhage following surgery for proliferative diabetic retinopathy (PDR). Single masked randomized-controlled clinical trial SUBJECTS: Consecutive patients with vitreous haemorrhage due to PDR undergoing primary vitreoretinal surgery were screened. After completing all vitreoretinal manoeuvres including endo-cautery to bleeders, infusion pressure was gradually reduced to 5 mmHg. Eyes with persistent bleeders at the macula and/or the optic nerve head not amenable to endo-cautery were included. Eyes with tractional retinal detachment more than 5-disc diameter areas and/or retinal breaks were excluded. Twenty eyes were randomized into 2 groups. Controls were treated with conventional surgery, while cases were additionally treated with fibrin glue application over the posterior bleeding sites. Vitreous haze due to early recurrent vitreous hemorrhage was graded at weeks 1 and 4 as the main efficacy outcome measure. Absence of macular membranes at 3 months was the main safety outcome measure. Mean age, frequency of pre-operative anti-VEGF injection or retinal photocoagulation, antiplatelet usage and mean intra-operative blood pressures were similar between the 2 groups. Mean surgery duration (54.6 min vs. 51.6 min) and frequency of fibrous proliferation > 2-disc diameter areas (7 each) was similar. Fine dissection with forceps and/or scissors was required in more cases than controls (6 vs. 3). Macular membranes were noted in one participant in each group. Mean grade of vitreous haze was significantly higher in controls than cases at week 1 (2.4 vs. 0.6, p=0.027) and week 4 (2 vs. 0, p=0.029). Cases had significantly better odds of having optically clear vitreous cavity at both weeks one (OR= 8.167, CI=1.02-64.03, p=0.047) and four (OR=33, CI= 1.43-760.67, p=0.029). Repeat retinal intervention for vitreous hemorrhage within 3 months was required in 5/10 controls, and in none of the cases. Our findings indicate fibrin glue application under direct visualization to be safe and efficacious in preventing recurrent vitreous hemorrhage for PDR in the early post-operative period.
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