Datafile 1.

Purpose
Symptoms and signs of dry eye can significantly increase after cataract surgery. The present study seeks to investigate the effect of intensive lubrication using Systane HYDRATION multi-dose preservative free (MDPF) eye drops (Alcon Research, Ltd., Fort Worth, Texas, USA) on signs and symptoms of dry eye in the postoperative phase.
Methods
Patients scheduled for cataract surgery were enrolled in this randomised, investigator-masked study and assigned to one of three groups. The risk of developing dry eye was stratified using the ocular surface frailty index (OSFI). The high risk – standard of care (HR-SOC) and treatment (HR-Treatment) group were the high-risk groups (OSFI 0.3 or greater), and the LR-SOC group was the low-risk group (OSFI less than 0.3). HR-SOC and LR-SOC group received the standard postoperative treatment. In the HR-Treatment group, Systane HYDRATION MDPF was added four times a day for three months after surgery. After the baseline examination prior to cataract surgery, three follow up visits were scheduled one week, one month and three months after surgery. OSDI scores, ocular surface staining, and fluorescein break-up time were assessed at each visit.
Results
Ninety-five patients were included and 83 entered statistical analyses. OSDI increased in all groups after cataract surgery, and it was lowest in the HR-Treatment group three months after the surgery. In addition, fluorescein break-up time tended to be longer and ocular surface staining less in the HR treatment group at three months. However, there was no statistically significant difference between the groups during the three-month visit.
Conclusion
In this randomized, examiner-masked trial no statistically significant difference could be found between the groups, but Systane HYDRATION MDPF may have a positive effect after cataract surgery in high-risk groups for dry eye syndrome.
Trial registration
ClinicalTrials.gov NCT06555224

研究目的
白内障术后干眼症（dry eye）的症状与体征可显著加重。本研究旨在评估使用Systane HYDRATION多剂量无防腐剂（multi-dose preservative free, MDPF）滴眼液（美国德克萨斯州沃斯堡爱尔康研究有限公司）实施强化润滑疗法，对术后阶段干眼症症状与体征的影响。

研究方法
本研究为随机、研究者设盲试验，纳入拟接受白内障手术（cataract surgery）的患者，并按随机原则分为三组。采用眼表脆弱指数（ocular surface frailty index, OSFI）对干眼症发病风险进行分层：OSFI≥0.3者为高风险人群，分为高风险标准治疗组（HR-SOC）与高风险强化治疗组（HR-Treatment）；OSFI<0.3者为低风险人群，纳入低风险标准治疗组（LR-SOC）。HR-SOC组与LR-SOC组仅接受标准术后治疗；HR-Treatment组在术后额外每日四次滴用Systane HYDRATION MDPF滴眼液，持续三个月。所有受试者在白内障手术前完成基线检查，并于术后1周、1个月及3个月完成三次随访。每次随访均评估OSDI评分（OSDI scores）、眼表染色结果及荧光素泪膜破裂时间（fluorescein break-up time）。

研究结果
本研究共纳入95例患者，最终83例完成统计分析。术后所有组的OSDI评分均升高，但术后3个月时HR-Treatment组的OSDI评分最低。此外，术后3个月时，HR-Treatment组的荧光素泪膜破裂时间更长，眼表染色程度更轻。但在术后3个月随访时，各组间的差异未达到统计学显著性水平。

研究结论
本项随机、检查者设盲试验中，各组间未观察到统计学显著性差异，但Systane HYDRATION MDPF滴眼液或可对白内障术后干眼症高风险人群产生积极干预效果。

试验注册
ClinicalTrials.gov NCT06555224