Mastropasqua Rodolfo, Gironi Matteo, D'Aloisio Rossella, Pastore Valentina, Boscia Giacomo, Vecchiarino Luca, Perna Fabiana, Clemente Katia, Palladinetti Ilaria, Calandra Michela, Piepoli Marina, Porreca Annamaria, Di Nicola Marta, Boscia Francesco
Ophthalmology Clinic, Department of Medicine and Science of Ageing, University "G. d'Annunzio" of Chieti-Pescara, Via dei Vestini 31, 66100 Chieti, Italy.
Eye Clinic, Department of Medical Science, Neuroscience and Sense Organs, University of Bari, 70121 Bari, Italy.
J Clin Med. 2023 Dec 22;13(1):76. doi: 10.3390/jcm13010076.
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.
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.
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%.
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.
在本研究中，我们旨在报告飞秒激光辅助小切口新一代可植入微型望远镜（SING-IMT™）植入对患有晚期年龄相关性黄斑变性（AMD）和白内障患者视觉功能及安全性的短期（6个月）影响，尤其与术后眼压升高相关。该装置专为单眼使用设计，旨在通过将图像投射到黄斑周围更大面积的光感受器上来最小化中心暗点的影响。
在这项前瞻性多中心观察性病例系列研究中，纳入了6例接受SING-IMT™植入术的患者的6只眼。在基线和随访6个月时，评估最佳矫正远视力（BCDV）、最佳矫正近视力（BCNVA）、眼压（IOP）、前房深度、内皮细胞计数。此外，还在术后第7天、15天、30天、45天以及随访3个月时测量眼压。最后，评估并发症的发生率。
在最终随访时，研究眼的平均BCDV提高了+10.0字母（6.25；13.8），平均BCNVA提高了-0.30 logMAR（-0.55；-0.20）。在术后第6个月，我们报告平均眼压降低了4.50 mmHg（-5.75；-0.25）。有趣的是，83.3%的患者在术后前两次随访（7天和15天）中的至少一次眼压值升高。在未进行术中机械性虹膜切开术的患者中，有必要进行术后YAG激光虹膜切开术以改善眼压管理。与基线相比，随访6个月时内皮细胞密度损失为12.6%。
发现SING IMT™装置在改善远视力和近视力方面有效，且无严重术后并发症。我们建议进行术中机械性虹膜切除术，以便轻松管理术后眼压并避免眼压突然升高及其可能的后果。这些良好结果有望部分改善患有严重晚期黄斑萎缩患者的生活质量。
