Application of platelet-rich fibrin membrane versus amniotic membrane graft transplantation after pterygium excision: a randomised clinical trial
摘要
To compare the efficacy and safety of platelet-rich fibrin (PRF) membrane and amniotic membrane graft (AMG) transplantation in preventing recurrence after primary pterygium excision.
MethodsThis prospective, single-blind, randomised clinical trial was conducted at Naresuan University Hospital. Eighty eyes with primary pterygium were randomly assigned to undergo either PRF membrane or AMG transplantation in a 1:1 ratio. Follow-up assessments were performed at 1 week, 1, 3, 6 and 12 months postoperatively. Outcomes included recurrence, surgical time, perioperative pain, complications, epithelialisation and the need for 5-fluorouracil (5-FU) injections. Recurrence was analysed using multilevel mixed-effects Poisson regression and Kaplan–Meier survival analysis.
ResultsAt 12 months, recurrence occurred in 41.7% of PRF eyes and 28.2% of AMG eyes (P = 0.22), with no significant difference in recurrence-free survival (P = 0.16). Better cosmetic outcomes were observed in the AMG group (P = 0.004). Surgical time was comparable between groups (37.2 vs 36.8 min; P = 0.81), while perioperative pain was higher in the PRF group (4.0 ± 1.9 vs 2.5 ± 2.1; P = 0.001). Complication rates and epithelialisation were similar between groups (P = 1.00 and P = 0.50, respectively). The PRF group required more 5-FU injections than the AMG group (80% vs 42.5%; P < 0.001).
ConclusionsPRF membrane grafting results in comparable recurrence and complication rates to AMG transplantation and is advantageous because of its simple preparation and autologous nature. However, the patients in PRF group had less favourable cosmetic outcomes.