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PresbyMAX Monocular模式矫正屈光不正合并老视的有效性和安全性 被引量:1

Effectiveness and Safety of PresbyMAX Monocular Module for the Correction of Ametropia Combined with Presbyopia
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摘要 目的:探讨PresbyMAX Monocular模式矫正屈光不正合并老视的临床有效性、安全性及可预测性。方法:前瞻性临床研究。连续纳入2020年12月至2021年8月在郑州华厦视光眼科医院行PresbyMAX Monocular模式下准分子激光手术的屈光不正合并老视患者50例。所有患者主导眼接受飞秒激光小切口角膜基质透镜取出术(SMILE),非主导眼接受PresbyMAX Monocular模式下的飞秒激光制瓣的准分子激光原位角膜磨镶术(FS-LASIK)。术前及术后1 d、1周、1个月、3个月检查患者的视力(LogMAR)、屈光度、立体视等,并记录手术满意度、并发症等。手术前后视力比较采用Wilcoxon符号秩和检验,手术后不同时间点视力总体差异比较采用Freidman M检验,多重比较采用Bonferroni检验,手术前后不同立体视锐度眼数分布差异比较采用χ^(2)检验。结果:术后3个月患者双眼裸眼远视力(BUDVA)100%达到0.22或以下,98%达到0.10或以下,86%达到0或以下;双眼裸眼近视力(BUNVA)100%达到0.22或以下,92%达到0.10或以下,78%达到0或以下。术后3个月BUDVA、BUNVA均较术前提高,差异均有统计学意义(Z=-6.10、-5.70,均P<0.001)。Freidman M检验示手术后不同时间点BUDVA之间、BUNVA之间比较差异均有统计学意义(χ^(2)=29.02、31.58,均P<0.001),其中术后1周、1个月、3个月的BUDVA和BUNVA均明显优于术后1 d,差异均有统计学意义(均P<0.05),术后1周、1个月、3个月间的BUDVA、BUNVA差异均无统计学意义(均P>0.05)。术后3个月主导眼和非主导眼的最佳矫正远视力、最佳矫正近视力与术前差异均无统计学意义(均P>0.05)。术后3个月主导眼等效球镜度(SE)在±0.25 D范围内者46%,在±0.50 D范围内者76%,在±0.75 D范围内者88%。术后3个月非主导眼SE为(-1.25±0.43)D,术前非主导眼预测SE为(-1.08±0.21)D,二者差值在±0.50 D范围内者占78%。手术前后不同立体视锐度眼数分布差异无统计学意义(χ^(2)=0.30,P=0.585)。术后3个月双眼远、近视力满意者分别占93%和91%。随访期间无严重手术相关并发症发生。结论:PresbyMAX Monocular模式矫正屈光不正合并老视具有较好的有效性、安全性、预测性,术后患者无显著矫正视力丢失、立体视丧失等手术相关并发症,患者有较高的满意度。 Objective:To investigate the clinical effectiveness,safety,and predictability of the PresbyMAX monocular mode in the correction of ametropia combined with presbyopia.Methods:Totally 50 patients with ametropia and presbyopia were included in this prospective clinical study.All participants underwent PresbyMAX monocular laser surgery in Zhengzhou Huaxia Pure Vision Eye Hospital from December 2020 to August 2021.Participants in this study underwent femtosecond laser small incision lenticule extraction in the dominant eye,and femtosecond laser-assisted laser in situ keratomileusis in the non-dominant eye in PresbyMAX monocular mode.Visual acuity,refraction,and stereopsis were examined before surgery,and 1 day,1 week,1 month,and 3 months after surgery.Additionally,surgical satisfaction and complications were also recorded.Wilcoxon signed rank sum test was used to compare visual acuity before and after surgery.Freidman M test was used to compare total visual acuity differences at different time points after surgery,Bonferroni test was used for multiple comparison,andχ^(2) test was used to compare the differences in the distribution of eyes with different stereoscopic acuity before and after surgery.Results:At 3 months after surgery,100%of patients'binocular uncorrected distance visual acuity(BUDVA)logMAR visual acuity reached 0.22 or below,98%reached 0.10 or below,and 86%reached 0 or below.And 100%of patients'binocular uncorrected near visual acuity(BUNVA)logMAR visual acuity reached 0.22 or less,92%reached 0.10 or less,and 78%reached 0 or less.By using Wilcoxon signed rank sum test,BUDVA and BUNVA at 3 months after operation were better than those before operation,and the differences were statistically significant(Z=-6.10 and-5.70,respectively,both P<0.001).By using Freidman M test,there were statistically significant differences of BUDVA and BUNVA between different time points after surgery(χ^(2)=29.02 and 31.58,respectively,both P<0.001).Among them,BUDVA and BUNVA at 1 week,1 month and 3 months after surgery were significantly higher than those at 1 day after surgery,with statistical significance(all P<0.05).There was no significant difference of BUDVA and BUNVA at 1 week,1 month and 3 months after surgery(all P>0.05).At 3 months after surgery,the best corrected distance visual acuity and the best corrected near visual acuity showed no significant difference with the values before surgery(both P>0.05).Spherical equivalent(SE)of dominant eye was 46%in the range of±0.25 D,76%in the range of±0.50 D,and 88%in the range of±0.75 D at 3 months after surgery.The mean SE of the non-dominant eye at 3 months after surgery was-1.25±0.43 D,while the predicted SE before surgery was-1.08±0.21 D.Among these,78%of patients exhibited a difference between the two values within the range of±0.50 D.Theχ^(2) test showed no significant difference in the distribution of eyes with different stereoscopic acuity before and after surgery(χ^(2)=0.30,P=0.585).At 3 months after surgery,93%and 91%of patients were satisfied with their binocular uncorrected distant and near vision.No serious surgery-related complications occurred during follow-up.Conclusions:LASIK surgery under PresbyMAX monocular mode for correction of ametropia with presbyopia has good safety,efficacy and predictability,with no significant loss of visual acuity or stereovision vision,and no other surgery-related complications.Consequently,patient satisfaction is high.
作者 马小倩 周远沛 孙红燕 荆洋 李晴 尹卫靖 刘苏冰 Xiaoqian Ma;Yuanpei Zhou;Hongyan Sun;Yang Jing;Qing Li;Weijing Yin;Subing Liu(Zhengzhou Huaxia Pure Vision Eye Hospital,Zhengzhou 450016,China)
出处 《中华眼视光学与视觉科学杂志》 CSCD 北大核心 2024年第11期838-844,共7页 Chinese Journal Of Optometry Ophthalmology And Visual Science
基金 三明市引导性科技项目(2023-S-33)
关键词 屈光不正 老视 PresbyMAX 飞秒激光小切口角膜基质透镜取出术 飞秒激光 准分子激光原位角膜磨镶术 ametropia presbyopia PresbyMAX femtosecond laser small incision lenticule extraction femtosecond laser in situ keratomileusis
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