Trial reportACS biomaterials science & engineering2026
A Clinical Trial Report: A Nasolacrimal Stent with Shape Memory as an Advanced Alternative to Silicone Products.
Trial report in ACS biomaterials science & engineering, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
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0 citing papers in PubMed.
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Silicone tubes have been used as nasolacrimal stents for over 40 years due to their excellent elastic and biocompatible properties. Nonetheless, long-standing clinical issues persist, including biofilm formation, insufficient tear drainage, and invasiveness during insertion through occluded ducts. To address these issues, a prospective, single-arm, open-label clinical study was performed with 16 patients over 20 weeks using a shape memory stent. The shape memory function reduces invasiveness through temporarily thinned insertion by pulling, followed by diameter expansion upon accumulation of inner-body heat energy (on-site programming). The unique semicrystalline surface suppresses bacterial adhesion due to the spreading of anti-fouling crystalline ridges and the consequent narrow widths of the adhesive amorphous regions, effectively suppressing bacterial adhesion and subsequent biofilm formation. Furthermore, in aligned patterns, water-impenetrable crystalline ridges facilitate the flow-down of tears to the absorbable amorphous regions, thereby improving the drainage efficiency. Consequently, the clinical success rate (Munk's score of 0-1) reached 78.6% with a significant decrease in tear meniscus height over 20 weeks and postoperative fluorescein dye disappearance test grades ≤2 in all patients. Four cautionary symptoms occurred, leading to early stent removal in two patients due to corneal abrasion and insertion-site granuloma. These results suggest that the shape memory stent is a promising noninferior option to the silicone stent.
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