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

Korean Journal of Ophthalmology 2021년 35권 1호 p.37 ~ 43
김보람, 김소현, 고재상, 백승운, 박융경, 김윤정, 윤진숙,
소속 상세정보
김보람 ( Kim Bo-Ram ) - Yonsei University College of Medicine Severance Hospital Department of Ophthalmology
김소현 ( Kim So-Hyun ) - Yonsei University College of Medicine Severance Hospital Department of Ophthalmology
고재상 ( Ko Jae-Sang ) - Yonsei University College of Medicine Severance Hospital Department of Ophthalmology
백승운 ( Baek Seung-Woon ) - Yonsei University College of Medicine Severance Hospital Department of Ophthalmology
박융경 ( Park Yung-Kyung ) - Ewha Womans University Department of Design
김윤정 ( Kim Yoon-Jung ) - Ewha Womans University Ewha Color Design Research Institute
윤진숙 ( Yoon Jin-Sook ) - Yonsei University College of Medicine Severance Hospital Department of Ophthalmology

Abstract


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 manufacturing methods 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. 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.

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, 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.

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 case series report.

키워드

Anophthalmos; Artificial eye; Computer-aided design; Sublimation technique; Three-dimensional printing

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