全飞秒激光角膜基质透镜植入术矫治中高度远视的一年随访研究

Allogeneic corneal small incision intrastromal lenticule inlays for moderate and high hyperopia： one year follow-up

目的评估全飞秒激光角膜基质透镜植入术矫治中高度远视的长期临床疗效。方法前瞻性自身对照系列病例观察研究。对29例53眼远视患者行同种异体角膜基质透镜植入术，并随访1年。术前远视度数为＋3.75～＋10 D，平均（＋6.84±2.95）D。分别于术前，术后1天、1周、1个月、3个月、6个月及1年观察裸眼远视力（UDVA）、裸眼近视力（UNVA）、最佳矫正远视力（BCDVA）和屈光度的矫治情况，并采用角膜地形图、光相干断层扫描（OCT）、眼反应仪等观察手术后角膜形态及角膜生物力学的改变。结果术后3个月、6个月和1年患者UDVA、UNVA均较术前明显提高，SE较术前明显减小，差异均有统计学意义（均P〈0.05），术后不同时间点UDVA、UNVA、等效球镜度（SE）两两比较，差异均无统计学（均P〉0.05）。术后1年14眼（占26.4%）BCDVA提高1行，12眼（占22.6%）BCDVA提高2行。仅2例患者3眼（占5.66%）术后由于出现排斥反应而BCDVA下降，更换角膜基质透镜后，所有眼均未见BCDVA下降。角膜地形图检查结果显示，术后3个月、6个月和1年角膜平均曲率值（Avek）较术前明显增高，表面规则指数（SRI）和表面不对称指数（SAI）也明显增大，中央角膜厚度（CCT）明显变厚，差异均有统计学意义（均P〈0.05），但术后不同时间点两两比较，差异均无统计学（均P〉0.05）。术后各时间点角膜OCT检查可见角膜基质植片在位、透明，术后1年角膜植片分界线仍然清晰可见。手术前后不同时间点角膜滞后量（CH）和角膜阻力因子（CRF）整体比较，差异均无统计学意义（F＝1.443，P＝0.216；F＝1.744，P＝0.128）。结论全飞秒角膜基质透镜植入术矫治中高度远视术后1年安全、有效，预测性好，为远视患者提供了新的手术方式选择。

Objective This study was to evaluate the long-term clinical efficiency of allogeneic corneal intrastromal lenticule inlay for correction of moderate and high hyperopia.MethodsA prospective self-controlled case series study was adopted.Twenty-nine hyperopic patients （53 eyes） were performed with allogeneic corneal intrastromal lenticule inlays.The range of preoperative spherical equivalent was ＋ 3.75 to ＋ 10 D, with the mean value of （＋ 6.84±2.95）D.All the cases were followed up for 1 year.Uncorrected and best corrected visual acuity and refraction were compared between before and after operation.Corneal topography and optical coherence topography were used to examine corneal topography.Ocular response analyzer was used to evaluate the shifts of corneal hysteresis.This study followed the Helsinki declaration, and the research process was approved by the Ethic Committee of Beijing Tongren Hospital, and informed consent was signed by each donor and receptor.ResultsCompared with the before surgery, the uncorrected distance visual acuity （UDVA） and uncorrected near visual acuity （UNVA） were obviously improved and the spherical equivalent （SE） was obviously decresed in 3 months, 6 months and 1 year after surgery, with significant differences between them（all at P〈0.05）, but no significant differences were found between each postoperative time points （all at P〉0.05）. One year after surgery, 14 eyes （26.4%） gained one line of best corrected distance visual acuity （BCDVA）, and 12 eyes （22.6%） gained two lines of BCDVA.Only 2 patients （5.66%） lost lines due to opaque lenticules, and no eye lost lines after changing the opaque lenticules.There was no obvious hyperopic fallback phenomenon.Compared with the before surgery, the average corneal curvature value （Avek） was obviously improved, the surface regularity index （SRI）, surface asymmetry index （SAI） and central corneal thickness （CCT） were obviously increased in 3 months, 6 months and 1 year after surgery, with significant differences between them （all at P〈0.05）, but no significant differences were found between each postoperative time points （all at P〉0.05）. The cornea optical coherence tomography （OCT） examination showed that, after the operation, the corneal stromal implant was in place and clear.One year after surgery, the dividing line of corneal graft was still clearly visible.No significant changes of corneal hysteresis （CH） and corneal resistance factor （CRF） were seen among different time points before and after surgeries （F=1.443, P=0.216; F=1.744, P=0.128）.ConclusionsAllogeneic corneal small incision intrastromal lenticule inlays can be used to correct moderate and high hyperopic eye with good safety, effectiveness and predictability.It provides a new choice for hyperopic patients.