Abstract
The purpose of this study was to investigate the effect of high molecular weight hyaluronan (HMWHA) eye drops on subbasal corneal nerves in patients suffering from severe dry eye disease (DED) and to evaluate the damage of subbasal corneal nerves associated with severe DED. Designed as an international, multicenter study, 16 patients with symptoms of at least an Ocular Surface Disease Index (OSDI) score of 33, and corneal fluorescein staining (CFS) of at least Oxford grade 3, were included and randomized into two study arms. The control group continued to use their individual optimum artificial tears over the study period of eight weeks; in the verum group, the artificial tears were substituted by eye drops containing 0.15% HMWHA. At the baseline visit, and after eight weeks, the subbasal nerve plexus of 16 patients were assessed by confocal laser scanning microscopy (CSLM). The images were submitted to a masked reading center for evaluation. Results showed a significant increase of total nerve fiber lengths (CNFL) in the HMWHA group (p = 0.030) when compared to the control group, where the total subbasal CNFL did not significantly change from baseline to week 8. We concluded that in severe DED patients, HMWHA from topically applied eye drops could cross the epithelial barrier and reach the subbasal nerve plexus, where it exercised a trophic effect.
Highlights
Millions of people worldwide are affected by dry eye disease (DED), a heterogeneous, complex disorder of the ocular surface [1]
We found a statistically significant difference in corneal nerve fiber length (CNFL) between baseline and the eight weeks follow-up visit; the Comfort Shield group showed a significant difference in CNFL (p = 0.030) contrary to the control group (p = 0.294)
Patients suffering from severe dry eye generally do not have a well-developed subbasal nerve plexus (SNP), and there was a lot of foreign tissue in the vicinity of the SNP that complicated the image analysis
Summary
Millions of people worldwide are affected by dry eye disease (DED), a heterogeneous, complex disorder of the ocular surface [1]. The combination of concentration and chain length of the HA molecules contained in these eye drops determines their viscoelastic and mucoadhesive properties, resulting in more or less entanglement and rheological synergism with the mucins dissolved in the muco-aqueous layer of the tear film. These physical properties of HA eye drops contribute to minimizing the friction between the moving eyelid and the surface of the eyeball during blinking, reducing known stimuli of ocular surface inflammation [3]. Future clinical investigations of HMWHA eye drops in humans suffering from chronic ocular surface inflammation should, include inflammation markers
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