Cung Hong Son, Tran Lan Huong Thi, Tran Thanh Ngoc
Vietnam National Eye Hospital, Ha Noi, Vietnam.
Hong Son Eye Hospital, Ha Noi, Vietnam.
Clin Ophthalmol. 2025 Feb 7;19:417-425. doi: 10.2147/OPTH.S502915. eCollection 2025.
To report the visual and refractive outcomes of small-incision lenticule extraction (SMILE) Pro using a 2 MHz femtosecond laser for myopic astigmatism in a large population of Vietnamese patients.
This was a retrospective clinical study of subjects that underwent keratorefractive lenticule extraction (KLEx) with the VISUMAX 800 at Hong Son Eye Hospital (Ha Noi, Vietnam) between June 2023 and October 2023. Primary outcome measures of monocular uncorrected distance visual acuity (UDVA), corrected distance visual acuity (CDVA), and refraction, including vector analysis, were evaluated at 3-months postoperatively. Secondary outcome measures of intraoperative and postoperative complications were also recorded.
A total of 765 eyes from 389 patients (60.66% women, mean age of 23.54±5.20 years) were analyzed 3 months after surgery. The mean preoperative spherical equivalent refraction was -5.98±2.26 D. The postoperative spherical equivalent refraction was within ±0.50 D of the intended target in 81% and within ±1.00 D in 97% of eyes. The mean spherical equivalent refraction was -0.11±0.45 D. UDVA was 20/25 or better in 92% and 20/32 or better in 97% of eyes. The mean postoperative UDVA and CDVA values were 0.05±0.09 and 0.00±0.02 logMAR, respectively. There was no change in CDVA in 99% of eyes. Efficacy index was 0.92, and safety index was 1.00. One eye (0.13%) had a suction loss, which resulted in a lenticule remnant. No other complications were reported during surgery or the postoperative follow-up period.
The current study, carried out on a large cohort of Asian patients, showed SMILE Pro with the VISUMAX 800 was safe and effective for treating myopic astigmatism.
报告使用2兆赫飞秒激光的小切口透镜切除术（SMILE）Pro在大量越南患者中治疗近视散光的视觉和屈光效果。
这是一项对2023年6月至2023年10月期间在越南河内鸿山眼科医院接受VISUMAX 800角膜屈光透镜切除术（KLEx）的受试者进行的回顾性临床研究。术后3个月评估单眼未矫正远视力（UDVA）、矫正远视力（CDVA）和屈光（包括矢量分析）的主要结局指标。还记录了术中和术后并发症的次要结局指标。
术后3个月对389例患者的765只眼（女性占60.66%，平均年龄23.54±5.20岁）进行了分析。术前平均等效球镜度为-5.98±2.26D。术后等效球镜度在预期目标的±0.50D范围内的眼占81%，在±1.00D范围内的眼占97%。平均等效球镜度为-0.11±0.45D。92%的眼UDVA为20/25或更好，97%的眼UDVA为20/32或更好。术后平均UDVA和CDVA值分别为0.05±0.09和0.00±0.02 logMAR。99%的眼CDVA无变化。有效指数为0.92，安全指数为1.00。1只眼（0.13%）出现吸引损失，导致透镜残留。手术期间或术后随访期间未报告其他并发症。
本研究在大量亚洲患者队列中进行，结果显示使用VISUMAX 800的SMILE Pro治疗近视散光安全有效。
