{"title":"人类首次应用脱细胞人羊膜水凝胶作为可注射眼内支架用于特发性全层黄斑大孔闭合：四个月的临床结果。","authors":"Jakkrit Juhong, Hathaichanok Impheng, Mukdawan Sukhang, Auemphon Mordmuang","doi":"10.1186/s40942-026-00893-4","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Large idiopathic full-thickness macular holes (FTMH) with minimum diameter > 400 μm carry surgical success rates of approximately 60% with standard vitrectomy and gas tamponade. Novel biologic scaffolds have improved closure rates but are limited by intraoperative handling challenges. We describe a surgical technique using thermosensitive injectable decellularized human amniotic membrane (dAM) hydrogel as an intraocular scaffold for large FTMH, and illustrate its feasibility and safety in a first-in-human application with four-month anatomical, functional, and electrophysiological outcomes.</p><p><strong>Surgical technique: </strong>A 62-year-old man with a Gass stage 4 idiopathic FTMH (minimum diameter 572 μm) and preoperative BCVA of 20/200 underwent combined phacoemulsification and 25-gauge pars plana vitrectomy (PPV) with ILM peeling. Following fluid-air exchange, dAM hydrogel (10 mg/mL, thermosensitive, prepared by detergent decellularization and pepsin solubilization) was injected via a 25-gauge soft-tip cannula, followed by SF6 gas tamponade. Pre-clinical biocompatibility was confirmed by CCK-8 assay and transwell invasion assay prior to clinical use.</p><p><strong>Outcomes: </strong>At one month, SD-OCT confirmed complete Type 1 anatomical closure and BCVA improved to 20/80. At four months (day 121), BCVA further improved to 20/40 + 1 (logMAR 0.30), with no metamorphopsia, IOP 12.7 mmHg, and sustained Type 1 closure with progressive ellipsoid zone (EZ) reconstitution on OCT. Multifocal ERG (103 segments) confirmed measurable foveal P1 responses (Ring 1: 34.19 nV/deg²) with normal central N1 implicit time (40.2 ms; normal range 36.8-46.4 ms). No intraocular adverse events occurred at any time point.</p><p><strong>Conclusions: </strong>This injectable dAM hydrogel scaffold technique is a feasible, instrument-sparing method for large FTMH repair, achieving stable Type 1 closure with progressive visual and electrophysiological recovery over four months. mfERG evidence of preserved foveal photoreceptor function supports its safety. Prospective comparative evaluation is ongoing (ClinicalTrials.gov: NCT06433284).</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov NCT06433284 (MACROHOLE trial). Registered April 2024.</p>","PeriodicalId":14289,"journal":{"name":"International Journal of Retina and Vitreous","volume":" ","pages":""},"PeriodicalIF":3.8000,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13563838/pdf/","citationCount":"0","resultStr":"{\"title\":\"First-in-human application of decellularized human amniotic membrane hydrogel as an injectable intraocular scaffold for large idiopathic full-thickness macular hole closure: four-month clinical outcomes.\",\"authors\":\"Jakkrit Juhong, Hathaichanok Impheng, Mukdawan Sukhang, Auemphon Mordmuang\",\"doi\":\"10.1186/s40942-026-00893-4\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Background: </strong>Large idiopathic full-thickness macular holes (FTMH) with minimum diameter > 400 μm carry surgical success rates of approximately 60% with standard vitrectomy and gas tamponade. Novel biologic scaffolds have improved closure rates but are limited by intraoperative handling challenges. We describe a surgical technique using thermosensitive injectable decellularized human amniotic membrane (dAM) hydrogel as an intraocular scaffold for large FTMH, and illustrate its feasibility and safety in a first-in-human application with four-month anatomical, functional, and electrophysiological outcomes.</p><p><strong>Surgical technique: </strong>A 62-year-old man with a Gass stage 4 idiopathic FTMH (minimum diameter 572 μm) and preoperative BCVA of 20/200 underwent combined phacoemulsification and 25-gauge pars plana vitrectomy (PPV) with ILM peeling. Following fluid-air exchange, dAM hydrogel (10 mg/mL, thermosensitive, prepared by detergent decellularization and pepsin solubilization) was injected via a 25-gauge soft-tip cannula, followed by SF6 gas tamponade. Pre-clinical biocompatibility was confirmed by CCK-8 assay and transwell invasion assay prior to clinical use.</p><p><strong>Outcomes: </strong>At one month, SD-OCT confirmed complete Type 1 anatomical closure and BCVA improved to 20/80. At four months (day 121), BCVA further improved to 20/40 + 1 (logMAR 0.30), with no metamorphopsia, IOP 12.7 mmHg, and sustained Type 1 closure with progressive ellipsoid zone (EZ) reconstitution on OCT. Multifocal ERG (103 segments) confirmed measurable foveal P1 responses (Ring 1: 34.19 nV/deg²) with normal central N1 implicit time (40.2 ms; normal range 36.8-46.4 ms). No intraocular adverse events occurred at any time point.</p><p><strong>Conclusions: </strong>This injectable dAM hydrogel scaffold technique is a feasible, instrument-sparing method for large FTMH repair, achieving stable Type 1 closure with progressive visual and electrophysiological recovery over four months. mfERG evidence of preserved foveal photoreceptor function supports its safety. Prospective comparative evaluation is ongoing (ClinicalTrials.gov: NCT06433284).</p><p><strong>Clinical trial registration: </strong>ClinicalTrials.gov NCT06433284 (MACROHOLE trial). Registered April 2024.</p>\",\"PeriodicalId\":14289,\"journal\":{\"name\":\"International Journal of Retina and Vitreous\",\"volume\":\" \",\"pages\":\"\"},\"PeriodicalIF\":3.8000,\"publicationDate\":\"2026-06-24\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13563838/pdf/\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"International Journal of Retina and Vitreous\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1186/s40942-026-00893-4\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q2\",\"JCRName\":\"OPHTHALMOLOGY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"International Journal of Retina and Vitreous","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1186/s40942-026-00893-4","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"OPHTHALMOLOGY","Score":null,"Total":0}
First-in-human application of decellularized human amniotic membrane hydrogel as an injectable intraocular scaffold for large idiopathic full-thickness macular hole closure: four-month clinical outcomes.
Background: Large idiopathic full-thickness macular holes (FTMH) with minimum diameter > 400 μm carry surgical success rates of approximately 60% with standard vitrectomy and gas tamponade. Novel biologic scaffolds have improved closure rates but are limited by intraoperative handling challenges. We describe a surgical technique using thermosensitive injectable decellularized human amniotic membrane (dAM) hydrogel as an intraocular scaffold for large FTMH, and illustrate its feasibility and safety in a first-in-human application with four-month anatomical, functional, and electrophysiological outcomes.
Surgical technique: A 62-year-old man with a Gass stage 4 idiopathic FTMH (minimum diameter 572 μm) and preoperative BCVA of 20/200 underwent combined phacoemulsification and 25-gauge pars plana vitrectomy (PPV) with ILM peeling. Following fluid-air exchange, dAM hydrogel (10 mg/mL, thermosensitive, prepared by detergent decellularization and pepsin solubilization) was injected via a 25-gauge soft-tip cannula, followed by SF6 gas tamponade. Pre-clinical biocompatibility was confirmed by CCK-8 assay and transwell invasion assay prior to clinical use.
Outcomes: At one month, SD-OCT confirmed complete Type 1 anatomical closure and BCVA improved to 20/80. At four months (day 121), BCVA further improved to 20/40 + 1 (logMAR 0.30), with no metamorphopsia, IOP 12.7 mmHg, and sustained Type 1 closure with progressive ellipsoid zone (EZ) reconstitution on OCT. Multifocal ERG (103 segments) confirmed measurable foveal P1 responses (Ring 1: 34.19 nV/deg²) with normal central N1 implicit time (40.2 ms; normal range 36.8-46.4 ms). No intraocular adverse events occurred at any time point.
Conclusions: This injectable dAM hydrogel scaffold technique is a feasible, instrument-sparing method for large FTMH repair, achieving stable Type 1 closure with progressive visual and electrophysiological recovery over four months. mfERG evidence of preserved foveal photoreceptor function supports its safety. Prospective comparative evaluation is ongoing (ClinicalTrials.gov: NCT06433284).
Clinical trial registration: ClinicalTrials.gov NCT06433284 (MACROHOLE trial). Registered April 2024.
期刊介绍：
International Journal of Retina and Vitreous focuses on the ophthalmic subspecialty of vitreoretinal disorders. The journal presents original articles on new approaches to diagnosis, outcomes of clinical trials, innovations in pharmacological therapy and surgical techniques, as well as basic science advances that impact clinical practice. Topical areas include, but are not limited to: -Imaging of the retina, choroid and vitreous -Innovations in optical coherence tomography (OCT) -Small-gauge vitrectomy, retinal detachment, chromovitrectomy -Electroretinography (ERG), microperimetry, other functional tests -Intraocular tumors -Retinal pharmacotherapy & drug delivery -Diabetic retinopathy & other vascular diseases -Age-related macular degeneration (AMD) & other macular entities
求助内容：
应助结果提醒方式：
京公网安备 11010802042870号
