[关键词]
[摘要]
目的:比较两种焦深延长衍射型人工晶状体(IOL)AMEUH与Tecnis Symfony植入术后临床效果的差异。
方法:前瞻性队列、多中心研究。选取2024年10月至2025年6月在3家医院行白内障超声乳化吸除联合IOL植入术的白内障患者。根据患者植入的IOL不同分为AMEUH组与ZXR00组,AMEUH组植入焦深延长衍射型IOL,ZXR00组植入Tecnis Symfony IOL。比较两组患者术后6 mo眼部生物学参数,明光下裸眼远视力(UDVA)、裸眼中视力(UIVA)、裸眼近视力(UNVA)、远矫正视力(CDVA)、远矫正下中视力(DCIVA)和远矫正下近视力(DCNVA),暗光下CDVA、DCIVA和DCNVA,离焦曲线,主觉验光,对比敏感度,视觉不良症状,脱镜率,患者满意度,眼压。
结果:本研究共纳入患者83例83眼,男31例31眼,女52例52眼,平均年龄63.18±10.30岁。AMEUH组41例41眼,年龄67.00(60.00,72.00)岁,男13例,女28例。ZXR00组42例42眼,年龄62.00(57.50,69.00)岁,男18例,女24例。完成术后6 mo随访者77例,失访6例(其中AMEUH组失访3例,ZXR00组失访3例)。术后6 mo,两组患者眼部生物学参数比较无显著差异(均P>0.05); 两组患者明光下UDVA、UIVA、UNVA、CDVA、DCIVA和暗光下CDVA、DCIVA比较无显著差异(均P>0.05),AMEUH组明光和暗光下DCNVA显著优于ZXR00组(均P<0.05); AMEUH组有效焦深较ZXR00组提升0.5 D; 两组患者主觉验光比较有显著差异(P<0.05); 不同光线条件部分空间频率下,AMEUH组对比敏感度显著优于ZXR00组(均P<0.05); AMEUH组眩光、光晕和视物模糊发生率显著低于ZXR00组(均P<0.05); 两组患者远、中、近距离脱镜率和远、中距离患者满意度比较无显著差异(均P>0.05),AMEUH组近距离患者满意度显著高于ZXR00组(P<0.05)。
结论:焦深延长衍射型IOL AMEUH在衍射设计基础上通过高次非球面扩景深设计进一步延长焦深,在远、中距离视力改善方面与Symfony IOL疗效相当,同时鉴于更高的附加光焦度能够提供更理想的近距离视力,并减少对眼镜的依赖。该IOL术后视觉不良症状发生率较低,安全性与患者满意度较高。
[Key word]
[Abstract]
AIM: To compare the postoperative clinical outcomes of two diffractive extended depth-of-focus intraocular lenses(IOLs), the AMEUH and the Tecnis Symfony IOL.
METHODS:This prospective cohort, multicenter study enrolled patients with cataract who underwent cataract phacoemulsification with IOL implantation at three hospitals between October 2024 and June 2025. Patients were divided into the AMEUH group and the ZXR00 group according to the implanted IOL. The AMEUH group included patients implanted with diffractive extended depth-of-focus IOL, and the ZXR00 group included patients implanted with the Tecnis Symfony IOL. At 6 mo postoperatively, ocular biometric parameters, photopic uncorrected distance visual acuity(UDVA), uncorrected intermediate visual acuity(UIVA), uncorrected near visual acuity(UNVA), corrected distance visual acuity(CDVA), distance-corrected intermediate visual acuity(DCIVA), and distance-corrected near visual acuity(DCNVA); mesopic CDVA, DCIVA, and DCNVA, defocus curves, manifest refraction, contrast sensitivity, adverse visual symptoms, spectacle independence, patient satisfaction, and intraocular pressure were compared between the two groups.
RESULTS:A total of 83 patients(83 eyes)were included in this study, including 31 males(31 eyes)and 52 females(52 eyes), with a mean age of 63.18±10.30 y. The AMEUH group included 41 patients(41 eyes), aged 67.00(60.00, 72.00)y, including 13 males and 28 females. The ZXR00 group included 42 patients(42 eyes), aged 62.00(57.50, 69.00)y, including 18 males and 24 females. The 77 patients completed 6 mo postoperative follow up, with 6 patients lost to follow up(3 from the AMEUH group and 3 from the ZXR00 group). There were no significant differences in ocular biometric parameters between the two groups postoperative 6 mo(all P>0.05). No significant differences were observed in photopic UDVA, UIVA, UNVA, CDVA, and DCIVA, or in mesopic CDVA and DCIVA between the two groups(all P>0.05). However,photopic and mesopic DCNVA in the AMEUH group were significantly better than in the ZXR00 group(both P<0.05). The effective depth-of-focus in the AMEUH group was increased by 0.5 D compared with the ZXR00 group. Significant differences were observed in manifest refraction between the two groups(P<0.05). Under specific lighting conditions and spatial frequencies, contrast sensitivity in the AMEUH group was significantly better than in the ZXR00 group(all P<0.05). The incidences of glare, halos, and blurred vision in the AMEUH group were all significantly lower than in the ZXR00 group(all P<0.05). There were no significant differences in spectacle independence for distance, intermediate, and near vision, or in patient satisfaction for distance and intermediate vision between the two groups(all P>0.05). However, patient satisfaction for near vision in the AMEUH group was significantly higher than in the ZXR00 group(P<0.05).
CONCLUSION:The diffractive extended depth-of-focus IOL AMEUH further extends the depth-of-focus through a higher-order aspheric optical design based on a diffractive design, providing comparable efficacy to the Symfony IOL in improving distance and intermediate vision. Meanwhile, benefiting from its higher add power, it provides superior near visual performance, and reduces spectacle dependence. The AMEUH IOL is associated with a lower incidence of postoperative adverse visual symptoms, as well as favorable safety, and high patient satisfaction.
[中图分类号]
[基金项目]
辽宁省科技计划联合计划面上项目(No.2025-MSLH-812)