Nethradhama Super Speciality Eye Hospital, 256/14, Kanakapura Main Road, 7th Block, Jayanagar, Bengaluru, Karnataka, 560070, India.
Int Ophthalmol. 2021 Aug;41(8):2657-2665. doi: 10.1007/s10792-021-01821-1. Epub 2021 Mar 31.
To determine the safety, efficacy and clinical outcomes of 100 µ versus 160 µ cap in patients undergoing ReLEx-Small Incision Lenticule Extraction (SMILE).
This prospective, comparative, non-randomized clinical trial included hundred eyes from 50 patients, undergoing bilateral ReLEx SMILE for myopia ranging from - 1 to - 6 D spherical equivalent. Twenty-five patients received treatment with standard 100 µ cap thickness, while the remaining 25 patients underwent the same procedure but with a 160 µ cap thickness in both eyes. Manifest refraction, UDVA, CDVA, contrast sensitivity, aberrations and dry eye were evaluated along with a subjective questionnaire at 2 weeks and 3 months post-operatively. Mean follow-up was 90 ± 15 days.
At two weeks and 3 months post-operative, compared to the preoperative values, the mean log-MAR UDVA, CDVA, spherical equivalent, contrast sensitivity higher order aberrations did not show statistically significant differences (p > .05) between the two study groups. However, significant reduction in Schirmer's II and TBUT scores was observed compared to preoperative scores at 3 months in 100 µ group (p > .05) but not in160 µ group. Patients did not report significant subjective complaints in either groups treated, when leading questions were asked through a subjective questionnaire.
ReLEx SMILE with 160 µ cap thickness was equally safe and efficacious as 100 µ cap, with no unique complications observed by keeping a thicker cap. Post-operative dry eye was significantly less in 160 µ group, suggesting an advantage in patients with pre existing dryness or contact lens users.
CTRI/2014/09/005,005.
评估 ReLEx 小切口微透镜切除术（SMILE）中 100µ 与 160µ 角膜帽厚度的安全性、有效性和临床结果。
这是一项前瞻性、对比、非随机临床试验，纳入了 50 例（100 只眼）近视患者，等效球镜范围为-1 至-6D。其中 25 例患者采用标准 100µ 角膜帽厚度进行治疗，其余 25 例患者双眼采用 160µ 角膜帽厚度进行治疗。术后 2 周和 3 个月时评估视力、远视力、最佳矫正视力、对比敏感度、像差和干眼情况，并进行主观问卷调查。平均随访时间为 90±15 天。
术后 2 周和 3 个月时，与术前相比，两组患者的平均 logMAR 远视力、最佳矫正视力、等效球镜、对比敏感度高阶像差均无统计学差异（p>.05）。然而，与术前相比，100µ 组术后 3 个月的 Schirmer Ⅱ和 TBUT 评分显著降低（p>.05），但 160µ 组无此变化。通过问卷调查询问主要问题时，两组患者均未报告明显的主观不适。
ReLEx SMILE 中采用 160µ 角膜帽厚度与 100µ 角膜帽厚度同样安全有效，且保持较厚的角膜帽并未观察到独特的并发症。160µ 组术后干眼症明显较少，提示对于有潜在干眼症或隐形眼镜使用者的患者有优势。
CTRI/2014/09/005,005.
