Abstract

The aim of this study was to evaluate the in vivo effects at 3 years of preservative-free tafluprost on corneal health. It was a prospective, masked, study on consecutive patients with a new prescription of preservative-free (PF) tafluprost (naïve-N or switched-S, 44 and 14 patients), and preserved (P) bimatoprost 0.003% or travoprost 0.004% (P-group, 35 patients). A complete ophthalmic examination and an in vivo corneal confocal microscopy evaluation were performed at baseline and every 6 months for 3 years. Ninety-three patients were enrolled, clinical parameters were similar in the groups at baseline, apart from intraocular pressure (IOP) which was lower in the S-group (p = 0.012). Both at baseline and over time, confocal microscopy parameters had different trends. At baseline, keratocyte activation was similar in the three groups (p = 0.43) but over the next months naïve patients treated with PF-tafluprost presented a significant (p = 0.004) reduction in keratocyte activation. Sub-basal nerves tended to increase in patients switched to PF-tafluprost (p = 0.07) while were stable in the other two groups (p = 0.11 in PF and 0.40 in P group). Grade of tortuosity was stable over time in the three groups. Beading-like formations were stable over time for the P- and the PF-group, while significantly increased in the S-group (p = 0.027). Endothelial density values were statistically different at baseline (p = 0.007), they decreased both in PF-group and in S-group (p = 0.048 and 0.001, respectively), while increased in P-group (p = 0.006). Our study is the first to show that a PF-tafluprost formulation does not significantly alter the corneal structures as examined by confocal microscopy after 36 months of topical daily therapy, while improving corneal alterations due to chronic preserved therapies.

Highlights

  • Glaucoma is a disease of the optic nerve: elevated intraocular pressure (IOP) has been recognized as the main risk factor for its development and progression

  • As underlined by the European Glaucoma Society (EGS) guidelines[5], the highest reduction of IOP is obtained with prostaglandins: this justifies the fact that most glaucoma patients are initially treated with a prostaglandin, as monotherapy

  • Confocal microscopy parameters differed in the three groups either at baseline (Table 2) or as trend over time (Fig. 1)

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Summary

Introduction

Glaucoma is a disease of the optic nerve: elevated intraocular pressure (IOP) has been recognized as the main risk factor for its development and progression. As underlined by the European Glaucoma Society (EGS) guidelines[5], the highest reduction of IOP is obtained with prostaglandins: this justifies the fact that most glaucoma patients are initially treated with a prostaglandin, as monotherapy. Ocular side effects are common among patients treated with this class of drug and may exacerbate ocular surface disorders, caused by the www.nature.com/scientificreports/. Topical medical treatment often become chronic, and long term topical glaucoma medications may exacerbate or cause ocular surface disease: the correlation between the use of benzalkonium chloride (BAK) -preserved anti-glaucoma medications and signs/symptoms of ocular surface disease has been widely recognized, as well as the reduction of signs/symptoms after the switch to unpreserved drugs[9,11,12]. Since confocal microscopy allows clinical insights at the cellular level, providing quantitative data about the healthy and the inflammatory and toxic changes of the ocular surface, the instrument has been introduced in the clinical use to evaluate ocular surface status in glaucoma patients[13,14]

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