Department of Ophthalmology, Institute of Vision Research, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
Department of Biomedical Engineering, Yonsei University College of Medicine, Seoul, Korea.
Korean J Ophthalmol. 2021 Feb;35(1):37-43. doi: 10.3341/kjo.2020.0125. Epub 2020 Dec 11.
We sought to evaluate the safety and effectiveness of patient-specific ocular prostheses produced by three-dimensional (3D) printing and the sublimation technique. A comparison with prostheses produced using manual manufacturing methods was then performed.
To confirm the biological and physiochemical safety, cytotoxicity, systemic acute toxicity, intradermal reaction, and skin sensitization tests were conducted according to the International Organization for Standardization guidelines. The compressive strength of the prostheses was also tested. Further, a case series of three patients who wore the 3D printed prostheses for more than eight hours daily for 4 weeks was executed. Self-assessments by these individuals using a questionnaire and safety evaluations focusing on the occurrence of conjunctival inflammation or allergic reactions according to the Cornea and Contact Lens Research Unit criteria by slit-lamp examination and similarity assessment were completed.
The 3D printed ocular prostheses met the necessary qualifications per the biological and physiochemical safety tests, showing the absence of cytotoxicity, acute systemic toxicity, intradermal reactivity, and skin-sensitizing potency. Also, there was no difference in strength test results between previous ocular prostheses and the 3D printed ones. Self-assessment by the patients yielded satisfactory results, with no significant difference in the level of satisfaction reported for the 3D printed and previous handmade ocular prostheses. The 3D printed prosthesis did not trigger any side effects in the conjunctival sac and showed similar objective findings with respect to the color of the iris, sclera, and vessel patterns.
Our study confirms the biologic and physiochemical safety of 3D-printed ocular prostheses created using computer-aided design technology and a sublimation technique. The patients' questionnaires and the judgment of the ophthalmologists/ocularists showed that the 3D printed ocular prosthesis was acceptable in function and appearance through a case series report.
我们旨在评估通过三维（3D）打印和升华技术制作的患者特异性义眼的安全性和有效性，并与使用手动制造方法制作的义眼进行比较。
为了确认生物和理化安全性，根据国际标准化组织的指南进行了细胞毒性、全身急性毒性、皮内反应和皮肤致敏试验。还测试了义眼的抗压强度。此外，还进行了一项包含三名患者的病例系列研究，这些患者每天佩戴 3D 打印义眼超过 8 小时，持续 4 周。这些患者通过问卷调查进行自我评估，并根据角膜和隐形眼镜研究单位的标准，通过裂隙灯检查和相似性评估，对结膜炎症或过敏反应的发生进行安全性评估。
3D 打印义眼通过了生物和理化安全性测试的必要条件，显示无细胞毒性、全身急性毒性、皮内反应和皮肤致敏性。此外，强度测试结果与之前的义眼没有差异。患者的自我评估结果令人满意，3D 打印和之前手工制作的义眼的满意度水平没有显著差异。3D 打印义眼在结膜囊中没有引发任何副作用，并且在虹膜、巩膜和血管模式的颜色方面具有相似的客观发现。
我们的研究证实了使用计算机辅助设计技术和升华技术制作的 3D 打印义眼具有生物和理化安全性。通过病例系列报告，患者的问卷调查和眼科医生/眼科学家的判断表明，3D 打印义眼在功能和外观上是可以接受的。
