PURPOSE: This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness (TFT) assessed with optical coherence tomography in patients with mild to moderate dry eye disease. METHODS: The study was performed in a randomized, double-masked, controlled parallel group design. Patients received a single dose of either unpreserved trehalose 30 mg/mL and sodium hyaluronate 1.5 mg/mL (TH-SH, Thealoz Duo), unpreserved sodium hyaluronate, 0.15% (HA, Hyabak) or sodium chloride, 0.9% (NaCl, Hydrabak) eye drops. Sixty patients finished the study according to the protocol. TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of 1.2 μm. RESULTS: The mean TFT before treatment was 2.5 ± 0.4 μm. Ten minutes after instillation, TFT significantly increased in the TH-SH group from 2.4 ± 0.4 to 3.1 ± 0.9 μm (P < 0.01) and in the HA group from 2.4 ± 0.3 to 2.9 ± 0.5 μm (P < 0.01), whereas no significant change was observed in the NaCl group (from 2.6 ± 0.4 to 2.7 ± 0.4 μm, P = 0.76). The increase in TFT remained statistically significant up to 240 minutes after administration of TH-SH. In contrast, the increase in TFT after administration of HA was only statistically significant at 10, 20, and 40 minutes after drop instillation. CONCLUSIONS: The findings of this study indicate that single instillation of TH-SH and HA eye drops increases TFT in patients with dry eye disease. The data also indicate longer corneal residence of the TH-containing eye drops. The effect of multiple instillation and long-term use of artificial tears on TFT warrants further investigation.
RCT Entities:
PURPOSE: This study was designed to investigate the effect of a single-drop instillation of different lacrimal substitutes on tear film thickness (TFT) assessed with optical coherence tomography in patients with mild to moderate dry eye disease. METHODS: The study was performed in a randomized, double-masked, controlled parallel group design. Patients received a single dose of either unpreserved trehalose 30 mg/mL and sodium hyaluronate 1.5 mg/mL (TH-SH, Thealoz Duo), unpreserved sodium hyaluronate, 0.15% (HA, Hyabak) or sodium chloride, 0.9% (NaCl, Hydrabak) eye drops. Sixty patients finished the study according to the protocol. TFT was measured with a custom-built ultrahigh-resolution Fourier domain optical coherence tomography system providing a resolution of 1.2 μm. RESULTS: The mean TFT before treatment was 2.5 ± 0.4 μm. Ten minutes after instillation, TFT significantly increased in the TH-SH group from 2.4 ± 0.4 to 3.1 ± 0.9 μm (P < 0.01) and in the HA group from 2.4 ± 0.3 to 2.9 ± 0.5 μm (P < 0.01), whereas no significant change was observed in the NaCl group (from 2.6 ± 0.4 to 2.7 ± 0.4 μm, P = 0.76). The increase in TFT remained statistically significant up to 240 minutes after administration of TH-SH. In contrast, the increase in TFT after administration of HA was only statistically significant at 10, 20, and 40 minutes after drop instillation. CONCLUSIONS: The findings of this study indicate that single instillation of TH-SH and HA eye drops increases TFT in patients with dry eye disease. The data also indicate longer corneal residence of the TH-containing eye drops. The effect of multiple instillation and long-term use of artificial tears on TFT warrants further investigation.
Authors: Antonio J Mateo Orobia; Paula Casas Pascual; José Á Cristóbal Bescós; Diana Perez García; Carlos Peiro Embid; M Ángeles Del Buey Sayas; Valentyna Korobko Kulikova; Noelia Lafuente Ojeda Journal: Clin Ophthalmol Date: 2017-02-16
Authors: Corinna Fischak; Robert Klaus; René M Werkmeister; Christine Hohenadl; Martin Prinz; Leopold Schmetterer; Gerhard Garhöfer Journal: J Ophthalmol Date: 2017-06-12 Impact factor: 1.909
Authors: Klemens Fondi; Piotr A Wozniak; Doreen Schmidl; Ahmed M Bata; Katarzyna J Witkowska; Alina Popa-Cherecheanu; Leopold Schmetterer; Gerhard Garhöfer Journal: J Ophthalmol Date: 2018-08-01 Impact factor: 1.909
Authors: Lóránt Dienes; Huba J Kiss; Kristóf Perényi; Zsuzsanna Szepessy; Zoltán Z Nagy; Árpád Barsi; M Carmen Acosta; Juana Gallar; Illés Kovács Journal: PLoS One Date: 2015-08-24 Impact factor: 3.240