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Abstract：
BACKGROUND: The purpose of our study was to compare the safety and efficacy of two scleral fixation intraocular lens (IOL) methods of four-point scleral fixation (Akreos AO60) and the Yamane technique (AcrySof MA60AC).
METHODS: This prospective, randomized study was conducted at the Military Institute of Medicine-National Research Institute in Warsaw between 2021 and 2023. We compared both groups for cause of aphakia, ocular history, refractive status, and complication.
RESULTS: Our study included 50 eyes from 47 patients. Four-point fixation was performed in 25 eyes (group 1), and the Yamane technique was used in 25 eyes (group 2). Surgical time was 24.1 min ± 8.9 in group 1 and 25.1 min ± 9.9 in group 2 (p > 0.05). The postoperative BCVA (best-corrected visual acuity) for group 1 and group 2 at 1 year\'s observation was 0.10 ± 0.15 and 0.09 ± 0.17 logMAR, respectively (p > 0.05). Postoperative total refractive error (RE) was - 0.06 ± 0.71 diopters (D) for four-point scleral fixation and 0.83 ± 0.70 D for Yamane technique (p < 0.05). Endothelial cell density (ECD) loss was 0.9% in group 1 and 3.5% in group 2 (p > 0.05). Bleeding into the anterior chamber and vitreous body was more frequent in the group of patients operated on with the use of the Yamane technique (10 cases, 20%, p = 0.01). IOL displacement was found in one case (2%) in group 2.
CONCLUSIONS: Both analyzed techniques are well tolerated and ensure good refractive results (extremely predictable in four-point scleral fixation) and have a similar safety profile. Four-point scleral fixation of IOL would appear to be safe, effective and beneficial for young, active patients, especially after trauma or recurrent subluxation.
BACKGROUND: ClinicalTrials.gov identifier NCT06389643.
METHODS: This prospective, randomized study was conducted at the Military Institute of Medicine-National Research Institute in Warsaw between 2021 and 2023. We compared both groups for cause of aphakia, ocular history, refractive status, and complication.
RESULTS: Our study included 50 eyes from 47 patients. Four-point fixation was performed in 25 eyes (group 1), and the Yamane technique was used in 25 eyes (group 2). Surgical time was 24.1 min ± 8.9 in group 1 and 25.1 min ± 9.9 in group 2 (p > 0.05). The postoperative BCVA (best-corrected visual acuity) for group 1 and group 2 at 1 year\'s observation was 0.10 ± 0.15 and 0.09 ± 0.17 logMAR, respectively (p > 0.05). Postoperative total refractive error (RE) was - 0.06 ± 0.71 diopters (D) for four-point scleral fixation and 0.83 ± 0.70 D for Yamane technique (p < 0.05). Endothelial cell density (ECD) loss was 0.9% in group 1 and 3.5% in group 2 (p > 0.05). Bleeding into the anterior chamber and vitreous body was more frequent in the group of patients operated on with the use of the Yamane technique (10 cases, 20%, p = 0.01). IOL displacement was found in one case (2%) in group 2.
CONCLUSIONS: Both analyzed techniques are well tolerated and ensure good refractive results (extremely predictable in four-point scleral fixation) and have a similar safety profile. Four-point scleral fixation of IOL would appear to be safe, effective and beneficial for young, active patients, especially after trauma or recurrent subluxation.
BACKGROUND: ClinicalTrials.gov identifier NCT06389643.
摘要：
背景：我们的研究目的是比较四点巩膜固定（AkreosAO60）和Yamane技术（AcrySofMA60AC）两种巩膜固定人工晶状体（IOL）方法的安全性和有效性。
方法：这种前瞻性，2021年至2023年在华沙的军事医学研究所-国家研究所进行了随机研究.我们比较了两组无晶状体眼的病因,眼部病史,屈光状态，和并发症。
结果：我们的研究包括47名患者的50只眼。25只眼进行四点固定（第1组），25只眼采用Yamane技术（第2组）。手术时间1组为24.1min±8.9,2组为25.1min±9.9(p>0.05)。第1组和第2组术后1年最佳矫正视力(BCVA)分别为0.10±0.15和0.09±0.17logMAR,分别为(p>0.05)。术后总屈光不正（RE）为-0.06±0.71屈光度（D），而Yamane技术为0.83±0.70D（p<0.05）。第1组和第2组的内皮细胞密度(ECD)损失分别为0.9%和3.5%(p>0.05)。在使用Yamane技术进行手术的患者组中，前房和玻璃体出血更为频繁（10例，20%,p=0.01)。在第2组中，1例（2％）发现IOL移位。
结论：两种分析技术均具有良好的耐受性，并确保良好的屈光效果（在四点巩膜固定术中非常可预测），并且具有相似的安全性。人工晶状体的四点巩膜固定似乎是安全的，对年轻人有效和有益，活跃的患者，尤其是在外伤或复发性半脱位后。
背景：ClinicalTrials.gov标识符NCT06389643。
方法：这种前瞻性，2021年至2023年在华沙的军事医学研究所-国家研究所进行了随机研究.我们比较了两组无晶状体眼的病因,眼部病史,屈光状态，和并发症。
结果：我们的研究包括47名患者的50只眼。25只眼进行四点固定（第1组），25只眼采用Yamane技术（第2组）。手术时间1组为24.1min±8.9,2组为25.1min±9.9(p>0.05)。第1组和第2组术后1年最佳矫正视力(BCVA)分别为0.10±0.15和0.09±0.17logMAR,分别为(p>0.05)。术后总屈光不正（RE）为-0.06±0.71屈光度（D），而Yamane技术为0.83±0.70D（p<0.05）。第1组和第2组的内皮细胞密度(ECD)损失分别为0.9%和3.5%(p>0.05)。在使用Yamane技术进行手术的患者组中，前房和玻璃体出血更为频繁（10例，20%,p=0.01)。在第2组中，1例（2％）发现IOL移位。
结论：两种分析技术均具有良好的耐受性，并确保良好的屈光效果（在四点巩膜固定术中非常可预测），并且具有相似的安全性。人工晶状体的四点巩膜固定似乎是安全的，对年轻人有效和有益，活跃的患者，尤其是在外伤或复发性半脱位后。
背景：ClinicalTrials.gov标识符NCT06389643。
