A Pilot Clinical Study of Ocular Prosthesis Fabricated by Three-dimensional Printing and Sublimation Technique

Purpose: 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 manufacturingmethods was then performed. Methods: 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. Thecompressive strength of the prostheses was also tested. Further, a case series of three patients who wore the 3D printedprostheses for more than eight hours daily for 4 weeks was executed. Self-assessments by these individuals using a questionnaireand safety evaluations focusing on the occurrence of conjunctival inflammation or allergic reactions according to theCornea and Contact Lens Research Unit criteria by slit-lamp examination and similarity assessment were completed. Results: 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, therewas no difference in strength test results between previous ocular prostheses and the 3D printed ones. Self-assessment bythe patients yielded satisfactory results, with no significant difference in the level of satisfaction reported for the 3D printedand previous handmade ocular prostheses. The 3D printed prosthesis did not trigger any side effects in the conjunctival sacand showed similar objective findings with respect to the color of the iris, sclera, and vessel patterns. Conclusions: 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 caseseries report.