背景:本研究旨在评估使用3D打印的丙烯酸树脂与常规聚甲基丙烯酸甲酯(PMMA)制造眼部假体对眼窝生物膜和微生物菌群的影响。
方法:设计了一项随机对照试验作为平行组研究。参与者被随机分为两组:对照组,接受常规制造的眼部假体(CG,n=11),和测试组,它接受了数字3D打印的眼部假体(DG,n=11)。在假体插入前和使用眼假体后三个月进行微生物分析。将拭子样品接种在血琼脂上,MacConkey\'s琼脂,和Sabouraud's葡萄糖琼脂(SDA)用于分离革兰氏阳性,革兰氏阴性,和真菌生物,分别。随后,将板在37摄氏度下孵育48小时。使用经过验证的问卷进行主观临床评估,包括舒适度等参数,插座放电,流泪,两组中每位人工眼患者的润滑频率。
结果:测试组(DG,n=11)表现出积极的,虽然统计上微不足道,与对照组相比,微生物生长差异(p>0.001)(CG,n=11)。两组患者的舒适度差异有统计学意义,Ⅱ组(试验组)患者内舒适度较高。而排放量等参数,放电位置,流泪和润滑频率显示两组之间无统计学差异,所有参数在使用假体3个月后均显示出改善的结果.
结论:眼假体制造技术的选择在眼科菌群方面没有统计学上的显著差异。然而,3D打印的丙烯酸树脂,作为一种人造眼材料,在减少机会性病原体定植方面显示出潜在的优势。所有主观临床评估参数在使用假体三个月后均表现出增强的结果,强调需要一个适应期,在此期间患者的抱怨得到缓解。与PMMA相比,3D打印丙烯酸树脂展示了一定程度的抗病原菌定植能力,以及显著的患者舒适度,这表明了它作为一种有前途的人工眼材料的潜力。
背景:此平行双盲RCT已在ClinicalTrials.gov注册,标识号为:NCT05584865,18/10/2022。
This study aims to assess the influence of using 3D-printed acrylic resin versus conventional Poly-methyl methacrylate (PMMA) for fabricating ocular prostheses on the biofilm and microbial flora of anophthalmic socket.
A randomized controlled trial was designed as a parallel group study. Participants were allocated randomly into two groups: the control group, which received conventionally fabricated ocular prostheses (CG, n = 11), and the test group, which received digitally 3D-printed ocular prostheses (DG, n = 11). Microbiological analysis was conducted before prosthesis insertion and three months after using the ocular prosthesis. Swab samples were inoculated on blood agar, MacConkey\'s agar, and Sabouraud\'s dextrose agar (SDA) for isolating Gram-positive, Gram-negative, and fungal organisms, respectively. Subsequently, the plates were incubated at 37 degrees Celsius for 48 h. Additionally, a validated questionnaire was used for subjective clinical evaluation, including parameters such as comfort level, socket discharge, lacrimation, and frequency of lubrication for each ocular prosthesis patient in both groups.
Test group (DG, n = 11) exhibited a positive, though statistically insignificant, difference (p > 0.001) in microbial growth when compared to the control group (CG, n = 11). A statistically significant difference was observed in comfort levels between the two groups, with more comfort level within group II (test group) patients. While parameters such as discharge amount, discharge location, lacrimation and lubrication frequency displayed statistically insignificant differences between the two groups, all parameters showed improved results after three months of prosthesis use.
The choice of ocular prosthesis fabrication technique did not yield a statistically significant difference in anophthalmic flora. However, the 3D-printed acrylic resin, as an artificial eye material, displayed potential advantages in reducing the colonization of opportunistic pathogens. All subjective clinical evaluation parameters exhibited enhanced outcomes after three months of prosthesis use, emphasizing the need for an adaptation period during which patients complains are alleviated. In comparison with PMMA, 3D-printed acrylic resin showcased a certain degree of anti-colonization ability against pathogenic bacteria, along with a significant level of patient comfort, suggesting its potential as a promising material for ocular prostheses.
This parallel double-blinded RCT has been registered at ClinicalTrials.gov with identification number: NCT05584865, 18/10/2022.