A Pilot Randomized Controlled Trial Evaluating Hemostasis With Fibrin Glue During Surgery for Proliferative Diabetic Retinopathy - 18/03/25
, Manasi Raj Ketkar, MS 2, Ritesh Narula, MS 1, 2, Mudit Tyagi, MS 2, Vivek Pravin Dave, MD 2, Raja Narayanan, MD 2Résumé |
Purpose |
To evaluate the safety and efficacy of fibrin glue in preventing early recurrence of vitreous hemorrhage following surgery for proliferative diabetic retinopathy (PDR).
Design |
Single-masked randomized controlled clinical trial.
Subjects |
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.
Methods |
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.
Main Outcome Measures |
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.
Results |
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.
Conclusion |
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.
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| Supplemental Material available at AJO.com. |
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| Meeting presentation: Early results were presented at the All India Ophthalmology Conference, March, 2024, at Kolkata, India; midterm results were accepted for presentation at the Asia Pacific Vitreo Retina Society Conference, November 2024, at Singapore; and also presented at the Vitreo Retina Society of India Conference, December 5, 2024, at Guwahati. |
Vol 272
P. 117-125 - avril 2025 Retour au numéro
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