Evaluation of a thermosensitive atelocollagen punctal plug treatment for dry eye disease – Accepted Manuscript

Abstract: Purpose: To evaluate the efficacy of a thermosensitive atelocollagen punctal plug in the treatment of dry eye disease.Design: Prospective observational case seriesMethods: Thermosensitive atelocollagen punctal plug (Keeptear, Koken Bioscience. Institutes, Japan) was warmed at 37, 39, 41 and 43 °C, to evaluate the appropriate temperature and time for solidification. Dry eye patients were divided into 2 groups according to the preparation method of atelocollagen punctal plug. In the conventional implantation group, atelocollagen gel was kept at room temperature for 15 minutes before implantation (27 eyes of 14 patients). In the pre-heating group, atelocollagen was warmed at 41 °C for 8 minutes before implantation (23 eyes of 13 dry eye patients). Strip meniscometry, vital stainings, tear film break-up time (BUT) and symptom scores were evaluated before and 1 month after plug implantation.Results: In vitro experiments revealed that heating at 41 °C for 8 min was sufficient to solidify the gel. The mean fluorescein score in the conventional implantation group significantly improved after treatment(before, 3.5±2.3 pts ; after, 2.5±0.9 pts. p< 0.05). In the pre-heating group, The mean fluorescein score (before,3.7±1.7pts; after, 1.5±1.2pts), strip meniscometry (before, 0.6±0.7mm; after, 1.1±0.3mm), BUT (before, 3.2±0.7s; after, 4.8±1.0s) and VAS scores(before, 6.6±1.5pts; after, 4.1±0.9pts) significantly improved after treatment (p< 0.05).Conclusion: Keeptear thermosensitive atelocollagen punctal plug was effective for dry eye treatment. Pre-heating method was found to be useful to strengthen the efficacy of thermosensitive atelocollagen punctal plug