A Pilot Randomized Controlled Trial Evaluating Hemostasis With Fibrin Glue During Surgery for Proliferative Diabetic...

To evaluate the safety and efficacy of fibrin glue in preventing early recurrence of vitreous hemorrhage following surgery for proliferative diabetic retinopathy (PDR).

Single-masked randomized controlled clinical trial.

Consecutive patients with vitreous hemorrhage due to PDR undergoing primary vitreoretinal surgery were screened. After completing all vitreoretinal maneuvers including endocautery to bleeders, infusion pressure was gradually reduced to 5 mm Hg. Eyes with persistent bleeders at the macula and/or the optic nerve head not amenable to endocautery 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, whereas 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 preoperative anti-vascular endothelial growth factor injection or retinal photocoagulation, antiplatelet usage, and mean intraoperative blood pressures were similar between the 2 groups. Mean surgery duration (54.6 vs 51.6 minutes) 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 1 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 = .027) and week 4 (2 vs 0, P = .029). Cases had significantly better odds of having optically clear vitreous cavity at both week 1 (odds ratio [OR] 8.167, CI 1.02-64.03; P = .047) and week 4 (OR 33, CI 1.43-760.67; P = .029). Repeat retinal intervention for vitreous hemorrhage within 3 months was required in 5 of 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 postoperative period.