Abstract
Purpose :
Platelet-rich autologous plasma (PRP) is a proven therapy for neurotrophic keratitis (NK), however studies on PRP usually focus on severe NK, are non-comparative and often are in combination (COMB) with preservative-free artificial tears (PFAT). The aim is to evaluate if PRP, PFAT or COMB are similar or more effective in treating stage 1 NK. This is a prospective, comparative, randomized, non-blinded cross-over clinical trial (NCT04604834).
Methods :
Patients aged 18-years or older with grade 1 NK on Mackie’s scale were enrolled between 2020-2023. Treatment groups began using PFAT, PRP or COMB and were intercrossed every 4 weeks. Intercrossing sequences were PFAT-PRP-COMB, PRP-PFAT-COMB and COMB-PFAT-PRP. Measurements were taken at baseline and at the end of each treatment. Evaluation included corneal sensitivity (CS), corneal fluorescein staining (CFS), Schirmer test (ST), Ocular Surface Disease Index (OSDI), tear breakup time (FBUT), and tear osmolarity (OSM). Paired T test, Wilcoxon signed-rank and Kruskall-wallis tests were used. Institutional ethics committee approval was received; all participants provided written informed consent.
Results :
50 eyes of 35 patients were included. No baseline significant differences were observed between groups. Mean baseline values in PFAT, PRP and COMB groups were: CS (2.4, 2.5, 2.3), CFS (5.8, 4.8, 5.4), ST(9.9, 11.4, 10.5), OSDI (38.1, 36.2, 34.7), FBUT(4.6, 4.2, 4.5), OSM (310.2, 310.5, 307.2). At 4 weeks before intercrossing all groups had improvement in CS (mean change(std. mean error): PFAT (-0.94(0.027) p=0.032), PRP (-0.68(0.17) p=0.017), COMB (-1.53(0.46) p=0.005); CFS improved only in PFAT (-0.06(0.29) p=0.022); OSDI improved in PFAT (17.1(5.76) p=0.009) and PRP (16.2(5.83) p=0.013); FBUT improved in PRP (-1.67(0.33) p=0.001). Response to treatment from baseline to end visit independently from intercrossing order: CS had improvement in all groups: PFAT(-0.36(0.18) p=0.027), PRP(-0.49(0.19) p=0.019), COMB(-0.64(0.35) p=0.004); CFS improved in PFAT (1.36(0.39) p=0.001) and COMB (0.78(0.33) p=0.024); OSDI improved in PFAT (6.54(2.48) P=0.011) and PRP (8.12(2.71) p=0.004); BCVA. improved in PFAT (0.13(0.06) p=0.031). No differences were observed in OSM.
Conclusions :
PRP alone or in combination with PFAT is an effective alternative for patients with stage 1 NK, as it improves corneal sensitivity, corneal staining, and ocular surface symptoms.
This abstract was presented at the 2024 ARVO Annual Meeting, held in Seattle, WA, May 5-9, 2024.