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Abstract：
OBJECTIVE: Evaluate postoperative visual performance in patients with bilaterally implanted AT LARA or AT LARA/AT LISA tri (Carl Zeiss AG, Jena, Germany) intraocular lenses.
METHODS: Multicentered, comparative, open-label, retrospective/prospective study. Post-IOL implantation, patients were prospectively enrolled into this study; preoperative patient data were collected retrospectively. Follow-up was at 2-4 and 5-8 months post-surgery. The primary endpoint was binocular best corrected distance visual acuity (CDVA). The study was retrospectively registered on clinicaltrials.gov (#NCT05462067).
RESULTS: Seventy-one patients (142 eyes) were enrolled; 67 patients (134 eyes) have 5-8 months data. The mean binocular CDVA at 2-4 months was -0.10 ± 0.06 logMAR in the bilateral AT LARA group (\"bilateral\") and -0.11 ± 0.09 logMAR in the combined implantation AT LARA/ AT LISA tri group (\"combined implantation\"); (P = 0.4856). At 5-8 months, mean binocular CDVA was -0.13 ± 0.06 logMAR in the bilateral group and -0.11 ± 0.09 in the combined implantation group (P = 0.4003). At 5-8 months, more eyes in the bilateral group attained 0.2 logMAR or better binocular uncorrected intermediate VA (UIVA; 67 cm) than those in the combined implantation group (100% vs. 94%, respectively). The bilateral group achieved a mean of 0.24 ± 0.11 logMAR in uncorrected near VA (UCNVA), compared to a mean of 0.16 ± 0.12 logMAR in the combined implantation group at 5-8 months (P = 0.0041).
CONCLUSIONS: A combined implantation approach (AT LARA in the distance dominant eye/AT LISA tri in the non-dominant eye) produced similar CDVA outcomes but better UCNVA as bilateral implantation with the AT LARA. UIVA was comparable between groups. No new safety concerns were reported.
METHODS: Multicentered, comparative, open-label, retrospective/prospective study. Post-IOL implantation, patients were prospectively enrolled into this study; preoperative patient data were collected retrospectively. Follow-up was at 2-4 and 5-8 months post-surgery. The primary endpoint was binocular best corrected distance visual acuity (CDVA). The study was retrospectively registered on clinicaltrials.gov (#NCT05462067).
RESULTS: Seventy-one patients (142 eyes) were enrolled; 67 patients (134 eyes) have 5-8 months data. The mean binocular CDVA at 2-4 months was -0.10 ± 0.06 logMAR in the bilateral AT LARA group (\"bilateral\") and -0.11 ± 0.09 logMAR in the combined implantation AT LARA/ AT LISA tri group (\"combined implantation\"); (P = 0.4856). At 5-8 months, mean binocular CDVA was -0.13 ± 0.06 logMAR in the bilateral group and -0.11 ± 0.09 in the combined implantation group (P = 0.4003). At 5-8 months, more eyes in the bilateral group attained 0.2 logMAR or better binocular uncorrected intermediate VA (UIVA; 67 cm) than those in the combined implantation group (100% vs. 94%, respectively). The bilateral group achieved a mean of 0.24 ± 0.11 logMAR in uncorrected near VA (UCNVA), compared to a mean of 0.16 ± 0.12 logMAR in the combined implantation group at 5-8 months (P = 0.0041).
CONCLUSIONS: A combined implantation approach (AT LARA in the distance dominant eye/AT LISA tri in the non-dominant eye) produced similar CDVA outcomes but better UCNVA as bilateral implantation with the AT LARA. UIVA was comparable between groups. No new safety concerns were reported.
摘要：
目的：评估双侧植入ATLARA或ATLARA/ATLISAtri的患者的术后视觉表现（CarlZeissAG，Jena,德国)人工晶状体。
方法：多输入，比较,开放标签，回顾性/前瞻性研究。人工晶体植入后,前瞻性地将患者纳入本研究;回顾性收集术前患者资料.随访时间为术后2-4个月和5-8个月。主要终点为双眼最佳矫正视力(CDVA)。该研究在clinicaltrials.gov（#NCT05462067）上进行了回顾性注册。
结果：纳入71例患者（142只眼）；67例患者（134只眼）有5-8个月的数据。2-4个月时，双侧ATLARA组（“双侧”）的平均双眼CDVA为-0.10±0.06logMAR，而联合植入ATLARA/ATLISA三联组（“联合植入”）的平均双眼CDVA为-0.11±0.09logMAR；（P=0.4856）。在5-8个月，双侧组平均双眼CDVA为-0.13±0.06logMAR,联合植入组为-0.11±0.09(P=0.4003).在5-8个月，与联合植入组相比，双侧组的眼睛达到0.2logMAR或更好的双眼未矫正中间VA（UIVA；67cm）（100％vs.94%,分别)。在未矫正的近VA（UCNVA）中，双侧组的平均logMAR为0.24±0.11，与5-8个月时联合植入组的平均0.16±0.12logMAR相比（P=0.0041）。
结论：联合植入方法（远处优势眼的ATLARA/非优势眼的ATLISAtri）产生了相似的CDVA结果，但UCNVA优于ATLARA的双侧植入。UIVA在组间具有可比性。没有新的安全问题报告。
方法：多输入，比较,开放标签，回顾性/前瞻性研究。人工晶体植入后,前瞻性地将患者纳入本研究;回顾性收集术前患者资料.随访时间为术后2-4个月和5-8个月。主要终点为双眼最佳矫正视力(CDVA)。该研究在clinicaltrials.gov（#NCT05462067）上进行了回顾性注册。
结果：纳入71例患者（142只眼）；67例患者（134只眼）有5-8个月的数据。2-4个月时，双侧ATLARA组（“双侧”）的平均双眼CDVA为-0.10±0.06logMAR，而联合植入ATLARA/ATLISA三联组（“联合植入”）的平均双眼CDVA为-0.11±0.09logMAR；（P=0.4856）。在5-8个月，双侧组平均双眼CDVA为-0.13±0.06logMAR,联合植入组为-0.11±0.09(P=0.4003).在5-8个月，与联合植入组相比，双侧组的眼睛达到0.2logMAR或更好的双眼未矫正中间VA（UIVA；67cm）（100％vs.94%,分别)。在未矫正的近VA（UCNVA）中，双侧组的平均logMAR为0.24±0.11，与5-8个月时联合植入组的平均0.16±0.12logMAR相比（P=0.0041）。
结论：联合植入方法（远处优势眼的ATLARA/非优势眼的ATLISAtri）产生了相似的CDVA结果，但UCNVA优于ATLARA的双侧植入。UIVA在组间具有可比性。没有新的安全问题报告。
