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临床试验/KCT0005526
KCT0005526已完成未知

Clinical evaluation of hydrogel lenses with water-soluble coating

Seoul National University of Science and Technology0 个研究点目标入组 21 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
入组人数
21

研究概览

简要总结

Contrast sensitivity test showed a significant decrease compared to before wearing in both groups as the wearing period increased in both the photopic vision and mesopic vision, but no difference was observed between the groups. The NIBUT showed a significant decrease according to the increase in wearing period compared to before wearing, and a statistically significant difference was shown between groups after 1 month of wearing. The degree of conjunctival and limbus congestion increased with the increase of the lens wearing period, and the non-coated lenses showed statistically significant changes, but there was no significant difference between groups. In the analysis of the OSDI questionnaire, when wearing non-coated lenses, there was a significant increase in subjective symptoms according to the lapse of the wearing period, but when wearing coated lenses, there was no significant increase between the 3rd and 4th weeks of wearing. In the analysis of the CLDEQ-8 questionnaire, discomfort caused by wearing non-coated lenses tended to be higher at 2 weeks and 4 weeks, but there was no significant difference between wearing time and groups. In the lens parameter analysis, the non-coated lens showed a significant difference from that of the new lens in center thickness, total diameter, radius of curvature, visible light and UV-A, UV-B transmittance. In the case of coated lenses, only the radius of curvature, visible light, and UV-A and UV-B transmittances showed significant differences from the new lenses. The radius of curvature of the lens showed an increase compared to the new lens (8.6mm), the diameter decreased compared to the new lens (14.2mm), but little changed, the central thickness decreased, and there was a significant difference between groups. The visible light transmittance decreased and the UV-A transmittance increased, while the UV-B transmittance decreased compared to the new lens (5%). The amount of protein adhesion was relatively large in the non-coated lens compared to the coated lens, but there was no significant difference. In the observation of the lens surface, the lens before wearing showed a smooth surface and there was no significant difference between the groups, while surface cracking was observed in both lenses after wearing.

研究设计

研究类型
Observational Study

入排标准

年龄范围
20(Year) 至 29(Year)(—)
性别
All

入选标准

  • TBUT is measured and selected as a target if both eyes are longer than 5 seconds

排除标准

  • TBUT is measured and one of both eyes is excluded from the subject if it is less than 5 seconds

研究者

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