ArticleInternational journal of retina and vitreous2026
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.
Article in International journal of retina and vitreous, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT06433284 (Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes), which is not on this map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Comparative Study of Decellularized Human Amniotic Membrane Hydrogel and Inverted Internal Limiting Membrane Flap in Idiopathic Large Macular Holes (MACROHOLE): a Randomized-control Trial
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundLarge 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.
conclusionsThis 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 registrationClinicalTrials.gov NCT06433284 (MACROHOLE trial). Registered April 2024.
Indexed as
Identifiers
What Socratic holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.