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| 新型硬性角膜接触镜润滑液安全性和有效性评价 |
| Safety and effectiveness evaluation of a new rigid contact lens lubricant |
| 投稿时间：2022-06-12 |
| DOI：10.3969/j.issn.1000-0399.2023.01.003 |
| 中文关键词: 硬性透气角膜接触镜 屈光不正 透明质酸纳 |
| 英文关键词: Rigid gas-permeable contact lens (RGPCL) Ametropia Sodium hyaluronate |
| 基金项目:安徽省重点研究与开发计划立项(编号:2022j11020013) |
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| 中文摘要: |
| 目的 评价一种国产新型硬性角膜接触镜润滑液的安全性和有效性。方法 选择2020年11月至2021年6月在安徽医科大学第二附属医院眼科门诊接受硬性角膜接触镜验配的近视患者为研究对象,共82例164只眼,使用计算机程序法随机分为试验组和对照组,每组41例82眼,试验组使用新型硬性角膜接触镜润滑液,对照组使用博士伦硬性角膜接触镜润滑液。观察并记录患者戴镜前、戴镜1周、1个月、3个月的检查结果,包括矫正视力、主观症状、泪膜破裂时间(BUT)、角膜荧光素染色评分、结膜充血情况。结果 两组患者矫正视力≥1.0的比例在戴镜1周、1个月、3个月差异均无统计学意义(P＞0.05),主观症状评分的差异也无统计学意义(P＞0.05),两组润滑液的有效性指标差异无统计学意义;两组患者在各时间点的BUT、角膜荧光素染色评分、结膜充血情况的差异均无统计学意义(P＞0.05),两组润滑液的安全性指标差异无统计学意义。结论 国产新型硬性角膜接触镜润滑液的临床应用安全有效。 |
| 英文摘要: |
| Objective To evaluate the safety and effectiveness of a new domestic rigid contact lens lubricant. Methods A total of 82 patients (164 eyes) with myopia who received rigid corneal contact lens fitting were enrolled from the Ophthalmology Clinic of the Second Affiliated Hospital of Anhui Medical University from December 2020 to June 2021. The patients were randomly divided into two groups, with 41 patients (82 eyes)in each group. The experimental group used the new rigid contact lens lubricant, and the control group used Bausch & Lomb rigid gas-permeable contact lens lubricant. The results of patients before and after 1 week, 1 month and 3 months wearing were observed and recorded, including corrected vision, subjective symptom, break-up time (BUT), fluorescein staining of corneal and conjunctival congestion. Results There was no significant difference in the proportion of corrected vision≥ 1.0 on 1 week, 1 month and 3 months (P>0.05); meanwhile, there was no significant difference in subjective symptom scores between the two groups (P>0.05). There was no significant difference in the effectiveness between the two groups. There was no significant difference in tear break-up time, fluorescein staining of corneal, and conjunctival congestion between the two groups at each time point (P>0.05). There was no significant difference in the safety between the two groups. Conclusions The new domestic rigid contact lens lubricant is safe and effective in clinical application. |
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