Son Hyeck-Soo, Yildirim Timur M, Khoramnia Ramin, Poompokawat Piyanut, Knorz Michael C, Auffarth Gerd U
J Refract Surg. 2020 Jul 1;36(7):474-480. doi: 10.3928/1081597X-20200519-01.
To clinically evaluate the efficacy and tolerability of semi-fluorinated alkane eye drops (EvoTears; URSAPHARM GmbH) as ocular surface treatment after cataract surgery in patients with evaporative dry eye disease.
This prospective, monocentric, open-label clinical trial included 40 patients undergoing cataract surgery and showing symptoms of evaporative dry eye disease as measured by the Symptom Assessment in Dry Eye (Visual Analogue Scale [VAS]) questionnaire, Ocular Surface Disease Index (OSDI), and tear break-up time (TBUT) of less than 10 seconds. EvoTears was prescribed four times a day for 5 weeks and administered 15 minutes after the standard postoperative topical anti-inflammatory regimen. The primary endpoint was the change in TBUT. Secondary endpoints included assessment of the subjective symptoms (VAS), corrected distance visual acuity (CDVA), slit-lamp examination, intraocular pressure, and Schirmer's test, which were evaluated at 1 day, 1 week, and 5 weeks postoperatively. At 5 weeks postoperatively, the tolerability and efficacy of EvoTears were evaluated by physicians and patients.
At 5 weeks postoperatively, the median TBUT increased from 6.8 (preoperative) to 14 seconds (P < .001) and the average total corneal staining score decreased from 3.53 (preoperative) to 2.36 (P < .001). The mean CDVA improved from 0.41 (preoperative) to 0.14 logMAR (P < .001) and there was a statistically significant decrease in all scores from the VAS questionnaire at 5 weeks postoperatively. There was no statistically significant change in Schirmer's test (P = .150).
EvoTears improved tear film, ocular surface, and subjective impressions of patients with dry eye disease 5 weeks after cataract surgery. Patients' and physicians' assessment indicated good efficacy and high tolerability of EvoTears, suggesting its suitability in postoperative management of the ocular surface in patients with dry eye disease. [J Refract Surg. 2020;36(7):474-480.].
临床评估半氟化烷烃眼药水(EvoTears;URSAPHARM GmbH公司)用于白内障手术后患有蒸发型干眼疾病患者眼表治疗的疗效和耐受性。
这项前瞻性、单中心、开放标签的临床试验纳入了40例接受白内障手术且表现出蒸发型干眼疾病症状的患者,这些症状通过干眼症状评估(视觉模拟量表[VAS])问卷、眼表疾病指数(OSDI)以及泪膜破裂时间(TBUT)小于10秒来衡量。EvoTears每天给药4次,持续5周,并在标准术后局部抗炎治疗方案后15分钟使用。主要终点是TBUT的变化。次要终点包括主观症状(VAS)、矫正远视力(CDVA)、裂隙灯检查、眼压和泪液分泌试验的评估,这些指标在术后1天、1周和5周进行评估。术后5周,由医生和患者评估EvoTears的耐受性和疗效。
术后5周,TBUT的中位数从6.8秒(术前)增加到14秒(P <.001),角膜总染色平均评分从3.53(术前)降至2.36(P <.001)。平均CDVA从0.41(术前)提高到0.14 logMAR(P <.001),术后5周VAS问卷的所有评分均有统计学意义的下降。泪液分泌试验无统计学显著变化(P =.150)。
EvoTears可改善白内障手术后5周干眼疾病患者的泪膜、眼表和主观感受。患者和医生的评估表明EvoTears具有良好的疗效和高耐受性,提示其适用于干眼疾病患者眼表的术后管理。[《屈光手术杂志》。2020;36(7):474 - 480。]