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Abstract：
BACKGROUND: In this study, we aimed to report the short-term (6 months) effects on visual functionality and safety of femto-laser assisted smaller-incision new-generation implantable miniature telescope (SING-IMT™) implanting, particularly related to postsurgical intraocular pressure increase, in patients suffering from end-stage age-related macular degeneration (AMD) and cataract. This device, designed for monocular use, aims to minimise the impact of the central scotoma by projecting the images onto a larger area of the photoreceptors surrounding the macula.
METHODS: In this prospective multicentric observational case series study, 6 eyes of 6 patients who underwent SING-IMT™ implantations were enrolled. At baseline and 6 months follow-up, best corrected distance visual acuity (BCDV) and best corrected near visual acuity (BCNVA), intraocular pressure (IOP), anterior chamber depth, endothelial cells count were assessed. In addition, IOP was also measured at 7, 15, 30, 45 days, and at 3 months follow-up. Finally, the incidence of complications was evaluated.
RESULTS: At final follow-up, in the study eyes, mean BCDVA improved by +10.0 letters (6.25; 13.8) letters and mean BCNVA improved by -0.30 logMAR (-0.55; -0.20). At postoperative month 6, we reported a mean IOP decrease of 4.50 mmHg (-5.75; -0.25). Interestingly, 83.3% of patients had an increased IOP value in at least one of the first two postoperative follow-ups (7 days and 15 days). In patients in whom intraoperative mechanical iridotomy was not performed, it was necessary to perform a postoperative YAG laser iridotomy to improve IOP management. Compared to the baseline, ECD loss at 6 months follow-up was 12.6%.
CONCLUSIONS: The SING IMT™ device was found to be effective in the distance and near vision improvement, without serious postoperative complications. We recommend intraoperative mechanical iridectomy in order to easily manage post-operative IOP and to avoid sudden IOP rise with its possible consequences. These good results can be a hope to partially improve the quality of life of patients suffering from severe end stage macular atrophy.
METHODS: In this prospective multicentric observational case series study, 6 eyes of 6 patients who underwent SING-IMT™ implantations were enrolled. At baseline and 6 months follow-up, best corrected distance visual acuity (BCDV) and best corrected near visual acuity (BCNVA), intraocular pressure (IOP), anterior chamber depth, endothelial cells count were assessed. In addition, IOP was also measured at 7, 15, 30, 45 days, and at 3 months follow-up. Finally, the incidence of complications was evaluated.
RESULTS: At final follow-up, in the study eyes, mean BCDVA improved by +10.0 letters (6.25; 13.8) letters and mean BCNVA improved by -0.30 logMAR (-0.55; -0.20). At postoperative month 6, we reported a mean IOP decrease of 4.50 mmHg (-5.75; -0.25). Interestingly, 83.3% of patients had an increased IOP value in at least one of the first two postoperative follow-ups (7 days and 15 days). In patients in whom intraoperative mechanical iridotomy was not performed, it was necessary to perform a postoperative YAG laser iridotomy to improve IOP management. Compared to the baseline, ECD loss at 6 months follow-up was 12.6%.
CONCLUSIONS: The SING IMT™ device was found to be effective in the distance and near vision improvement, without serious postoperative complications. We recommend intraoperative mechanical iridectomy in order to easily manage post-operative IOP and to avoid sudden IOP rise with its possible consequences. These good results can be a hope to partially improve the quality of life of patients suffering from severe end stage macular atrophy.
摘要：
背景：在这项研究中，我们的目的是报告短期（6个月）对视觉功能和安全性的影响飞激光辅助小切口新一代可植入微型望远镜（SING-IMT™）植入，特别是与术后眼压升高有关，在患有终末期年龄相关性黄斑变性（AMD）和白内障的患者中。这个装置,专为单眼使用而设计，旨在通过将图像投影到黄斑周围的更大区域的光感受器上来最大程度地减少中央暗点的影响。
方法：在这项前瞻性多中心观察性病例系列研究中，纳入6例接受SING-IMT™植入的患者的6只眼。在基线和6个月随访时，最佳矫正视力（BCDV）和最佳矫正视力（BCNVA），眼内压（IOP），前房深度,评估内皮细胞计数.此外,还在7、15、30、45天测量了IOP，并在3个月的随访。最后,评估并发症的发生率。
结果：在最后的随访中，在研究的眼睛，平均BCDVA提高了+10.0个字母(6.25;13.8),平均BCNVA提高了-0.30logMAR(-0.55;-0.20)。术后6个月，我们报告平均IOP下降4.50mmHg（-5.75;-0.25）。有趣的是,83.3％的患者在前两次随访（7天和15天）中至少有一次IOP值升高。在未进行术中机械虹膜切开术的患者中，有必要在术后进行YAG激光虹膜切开术以改善IOP管理.与基线相比，随访6个月时ECD损失率为12.6%。
结论：发现SINGIMT™装置可有效改善远距和近视力，无严重术后并发症。我们建议术中机械虹膜切除术，以轻松管理术后眼压并避免眼压突然升高及其可能的后果。这些良好的结果可以希望部分改善患有严重终末期黄斑萎缩的患者的生活质量。
方法：在这项前瞻性多中心观察性病例系列研究中，纳入6例接受SING-IMT™植入的患者的6只眼。在基线和6个月随访时，最佳矫正视力（BCDV）和最佳矫正视力（BCNVA），眼内压（IOP），前房深度,评估内皮细胞计数.此外,还在7、15、30、45天测量了IOP，并在3个月的随访。最后,评估并发症的发生率。
结果：在最后的随访中，在研究的眼睛，平均BCDVA提高了+10.0个字母(6.25;13.8),平均BCNVA提高了-0.30logMAR(-0.55;-0.20)。术后6个月，我们报告平均IOP下降4.50mmHg（-5.75;-0.25）。有趣的是,83.3％的患者在前两次随访（7天和15天）中至少有一次IOP值升高。在未进行术中机械虹膜切开术的患者中，有必要在术后进行YAG激光虹膜切开术以改善IOP管理.与基线相比，随访6个月时ECD损失率为12.6%。
结论：发现SINGIMT™装置可有效改善远距和近视力，无严重术后并发症。我们建议术中机械虹膜切除术，以轻松管理术后眼压并避免眼压突然升高及其可能的后果。这些良好的结果可以希望部分改善患有严重终末期黄斑萎缩的患者的生活质量。
