Taloni Andrea, Coco Giulia, Pellegrini Marco, Scorcia Vincenzo, Giannaccare Giuseppe
Department of Ophthalmology, University Magna Graecia of Catanzaro, Catanzaro, Italy.
Department of Clinical Sciences and Translational Medicine, University of Rome Tor Vergata, Rome, Italy.
Ophthalmic Res. 2025;68(1):41-51. doi: 10.1159/000542149. Epub 2024 Dec 2.
The aim of the study was to systematically review the evidence from randomized controlled trials that evaluate the efficacy and safety of perfluorohexyloctane in the treatment of dry eye disease.
Literature search was conducted on PubMed and Scopus in April 2024 with the search strategy ("perfluorohexyloctane" or "NOV03" or "semifluorinated alkane") and "dry eye." Extension and paired-eyes study were excluded. The risk of bias was assessed using the Cochrane risk-of-bias tool. Forest plots and a summary of findings were prepared for total corneal fluorescein staining (tCFS), tear film break-up time (TFBUT), eye dryness score (EDS), and Ocular Surface Disease Index (OSDI).
The pooled standardized mean difference (SMD) for tCFS after 8 weeks of treatment was -0.53 (95% CI: -0.68 to -0.38; p < 0.001), indicating a significant improvement in patients treated with perfluorohexyloctane. The between-study heterogeneity was moderately high (I2 = 52.0%). No significant differences in TFBUT were observed (SMD = 0.05; 95% CI: -0.16 to 0.25; p = 0.654). Regarding symptoms, patients treated with NOV03 had significantly lower EDS compared to controls (SMD = -0.49; 95% CI: -0.66 to -0.32; p < 0.001), with moderately high heterogeneity (I2 = 71.1%). Conversely, the pooled SMD of OSDI was -0.13 (95% CI: -0.43 to 0.17; p = 0.412), indicating no significant difference.
Perfluorohexyloctane is an effective and safe alternative for the treatment of evaporative dry eye disease due to MGD that can significantly reduce tCFS and eye dryness symptoms. More well-designed non-sponsored randomized clinical trials are required to investigate the impact on other ocular surface parameters.
本研究的目的是系统评价随机对照试验的证据，以评估全氟己基辛烷治疗干眼症的疗效和安全性。
2024年4月在PubMed和Scopus上进行文献检索，检索策略为（“全氟己基辛烷”或“NOV03”或“半氟化烷烃”）和“干眼症”。排除延长研究和双眼研究。使用Cochrane偏倚风险工具评估偏倚风险。为总角膜荧光素染色（tCFS）、泪膜破裂时间（TFBUT）、眼干评分（EDS）和眼表疾病指数（OSDI）绘制森林图并总结研究结果。
治疗8周后tCFS的合并标准化均数差（SMD）为-0.53（95%CI：-0.68至-0.38；p<0.001），表明全氟己基辛烷治疗的患者有显著改善。研究间异质性中等偏高（I2=52.0%）。未观察到TFBUT有显著差异（SMD=0.05；95%CI：-0.16至0.25；p=0.654）。关于症状，与对照组相比，接受NOV03治疗的患者EDS显著更低（SMD=-0.49；95%CI：-0.66至-0.32；p<0.001），异质性中等偏高（I2=71.1%）。相反，OSDI的合并SMD为-0.13（95%CI：-0.43至0.17；p=0.412），表明无显著差异。
全氟己基辛烷是治疗睑板腺功能障碍所致蒸发型干眼症的一种有效且安全的替代方法，可显著降低tCFS和眼干症状。需要更多设计良好的非资助随机临床试验来研究其对其他眼表参数的影响。
