1%羧甲基纤维素钠治疗白内障超声乳化术后干眼的疗效：一项多中心、开放标签、随机对照研究的结果
Efficacy of 1% carboxymethylcellulose sodium for treating dry eye after phacoemulsification: results from a multicenter, open-label, randomized, controlled study.
作者信息
Yao Ke, Bao Yongzhen, Ye Jian, Lu Yi, Bi Hongsheng, Tang Xin, Zhao Yune, Zhang Jinsong, Yang Jinling
机构信息
Eye Center, Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
Peking University People's Hospital, Beijing, China.
出版信息
BMC Ophthalmol. 2015 Mar 20;15:28. doi: 10.1186/s12886-015-0005-3.
BACKGROUND
For patients who experience dry eye after phacoemulsification, vision and quality of life can significantly deteriorate. In this study, the efficacy and safety of carboxymethylcellulose sodium (CMC) 1% ophthalmic solution combined with conventional therapy in treating dry eye signs and symptoms after phacoemulsification were evaluated.
METHODS
In this prospective, multicenter, open-label, controlled study, 180 patients with age-related cataract were randomized to treatment with conventional therapy plus CMC 1% (n = 90) or to conventional therapy only (control group, n = 90) after phacoemulsification and intraocular lens implantation. Tear breakup time (TBUT), the Schirmer test with anesthesia, and fluorescein and lissamine green staining were performed. The Ocular Surface Disease Index (OSDI) questionnaire and a patient subjective symptom evaluation were administered preoperatively (baseline) and postoperatively at 7 and 30 days.
RESULTS
TBUT was significantly longer in the treatment group compared with the control group at day 7 (8.5 ± 5.5 versus 6.6 ± 3.8 s; P = 0.0475) and day 30 (9.0 ± 5.9 versus 6.7 ± 4.8 s; P = 0.0258) after surgery. Compared with baseline, TBUT significantly increased in patients in the treatment group (P < 0.001 at both day 7 and day 30) with a presurgical diagnosis of dry eye, but significantly decreased in patients in the control group (P < 0.02 at both day 7 and day 30) with no prior diagnosis of dry eye. Fluorescein and lissamine staining, OSDI questionnaire and subjective symptom scores all improved from baseline, with no significant differences between the two groups. No significant differences in tolerability and safety were observed between the group receiving CMC and conventional therapy, and those receiving conventional therapy only.
CONCLUSION
Treatment with CMC 1% can provide significant improvement in tear film stability after phacoemulsification for age-related cataract.
TRIAL REGISTRATION
ClinicalTrials.gov identifier NCT02028754 (Date of registration: Jan. 6, 2014).
背景
对于白内障超声乳化术后出现干眼的患者，视力和生活质量会显著下降。本研究评估了1%羧甲基纤维素钠（CMC）滴眼液联合传统疗法治疗白内障超声乳化术后干眼体征和症状的疗效及安全性。
方法
在这项前瞻性、多中心、开放标签、对照研究中，180例年龄相关性白内障患者在白内障超声乳化及人工晶状体植入术后，随机分为接受传统疗法加1% CMC治疗组（n = 90）或仅接受传统疗法对照组（n = 90）。进行泪膜破裂时间（TBUT）、表面麻醉下的Schirmer试验、荧光素和丽丝胺绿染色。术前（基线）以及术后7天和30天进行眼表疾病指数（OSDI）问卷调查和患者主观症状评估。
结果
术后第7天（8.5±5.5秒对6.6±3.8秒；P = 0.0475）和第30天（9.0±5.9秒对6.7±4.8秒；P = 0.0258），治疗组的TBUT显著长于对照组。与基线相比，术前诊断为干眼的治疗组患者TBUT显著增加（第7天和第30天P均<0.001），而术前无干眼诊断的对照组患者TBUT显著降低（第7天和第30天P均<0.02）。荧光素和丽丝胺染色、OSDI问卷调查和主观症状评分均较基线改善，两组间无显著差异。接受CMC联合传统疗法的组与仅接受传统疗法的组在耐受性和安全性方面未观察到显著差异。
结论
1% CMC治疗可显著改善年龄相关性白内障超声乳化术后的泪膜稳定性。
试验注册
ClinicalTrials.gov标识符NCT02028754（注册日期：2014年1月6日）
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