Beijing Tongren Hospital, Beijing Tongren Eye Center, Capital Medical University, Beijing, 100730, China.
BMC Ophthalmol. 2024 Aug 14;24(1):344. doi: 10.1186/s12886-024-03587-3.
To investigate the safety and effectiveness of non-viscoelastic agent technique for EVO-ICL implantation.
A total of 181 myopia eyes that underwent non-toric ICL without viscoelastic agent through single incision from Beijing Tongren Hosipital were included. An analysis was conducted on the quantity of haptics that were initially implanted intraoperatively into the posterior chamber. Intraocular pressure (IOP) was evaluated at before and 2 h,24 h,1week,6month after surgery. Anterior chamber volume(ACV), anterior chamber depth(ACD), anterior chamber angle(ACA), pupil diameter(PD) and corneal densitometry density (ECD) were evaluated at before and 24 h postoperatively. Refractive outcomes were investigated at before, 24 h ,7 days and 6months. Vault was evaluated at 24 h ,7 days and 6months.
The efficacy and safety indices were 1.30 ± 0.32 and 1.31 ± 0.32, respectively. Of 181 eyes, 99 eyes received 4 haptics on the first attempt without any adjustment, and 72 eyes received lens alignment without an viscoelastic agent. The success rate of the viscoelastic agent free procedure was 94.5%. Two hours postoperatively, IOP was 17.41 ± 3.77 mmHg, which was significantly higher than baseline value (t = 8.930, P < 0.000), however there was no significant difference between preoperative IOP and IOP at 1 day ,1 week and 6 months postoperatively. The ECD changed from 2895.52 ± 253.73 cells/mm2 preoperatively to 2873.66 ± 244.17 cells/mm2 at 1 day and 2882.63 ± 239.97 postoperatively, and the difference was not statistically significant (t = 1.811, P = 0.072). The ACA was narrowed by 42% on the first day.
The pure viscoelastic agent free technique is an efficient and safe way for ICL implantation. It can be a safer method of ICL implantation because of it reduces the risk of complications associated with ocular hypertension at the early postoperative stages.
Chinese Clinical Trial Registry (ChiCTR2000036335) at August 20, 2020.
研究非黏弹剂技术在 EVO-ICL 植入术中的安全性和有效性。
共纳入北京同仁医院通过单切口植入非散光 ICL 且未使用黏弹剂的 181 例近视眼。分析术中首次植入后房的襻数量。术前及术后 2 h、24 h、1 周、6 个月评估眼压(IOP)。术前及术后 24 h 评估前房容积(ACV)、前房深度(ACD)、前房角(ACA)、瞳孔直径(PD)和角膜密度(ECD)。术前、术后 24 h、7 天和 6 个月评估屈光状态。术后 24 h、7 天和 6 个月评估拱高。
有效指数和安全性指数分别为 1.30±0.32 和 1.31±0.32。181 只眼中,99 只眼首次尝试植入 4 个襻,无需任何调整,72 只眼未使用黏弹剂即可对齐晶状体。无黏弹剂手术的成功率为 94.5%。术后 2 h,IOP 为 17.41±3.77mmHg,明显高于基础值(t=8.930,P<0.000),但术前 IOP 与术后 1 天、1 周和 6 个月时的 IOP 无显著差异。ECD 从术前的 2895.52±253.73 个细胞/mm2降至术后 1 天的 2873.66±244.17 个细胞/mm2和术后的 2882.63±239.97 个细胞/mm2,差异无统计学意义(t=1.811,P=0.072)。术后第 1 天,ACA 缩小 42%。
单纯无黏弹剂技术是 ICL 植入术的一种有效、安全的方法。由于它降低了术后早期与眼压升高相关的并发症风险,因此可能是一种更安全的 ICL 植入方法。
中国临床试验注册中心(ChiCTR2000036335),2020 年 8 月 20 日。