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

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.

An alternative technique by using digital photography and UV printing for fabricating a custom made ocular prosthesis

“…Until recently, there was no objective, defined method for producing ocular prosthetics with 3D printers. 24 In our technique there is no photograph paper or sublimation paper. Just painting process is only surface on the scleral blank.…”

Utilizing 3D Printing Technology to Create Prosthetic Irises: Proof of Concept and Workflow

“…Achieving a prosthesis that aesthetically matches the color of the other eye was also an important step for creating such a prosthesis, which aims to improve the quality of life for aniridia patients. While 3D printing technologies have been utilized in the production of ocular prostheses with an iris design that is either hand-painted [26], printed utilizing a sublimation technique [27,28], or produced in a single print job utilizing non-silicone material [22], these results advance the field by utilizing 3D printing with silicone inks to generate an aesthetically color-matched iris. One of the challenges of 3D printing an iris is the development of appropriate color inks that resemble the natural eye and printing structural details to create the natural texture of the iris with crypts and folds.…”

3D Printing in Eye Care

“…3D-printed scleral shells can be printed from either CT or corneoscleral topography scans and undergo standard post-fitting modifications such as iris art and acrylic finish [ 109 – 111 ]. Two authors have described a method for avoiding the manual artwork by printing a shell and layering on an iris with a sublimation transfer method [ 112 , 113 ]. The resulting product met safety standards including cytotoxicity and tissue reactivity and had strength testing comparable to that of conventional prostheses [ 112 ].…”

“…Two authors have described a method for avoiding the manual artwork by printing a shell and layering on an iris with a sublimation transfer method [ 112 , 113 ]. The resulting product met safety standards including cytotoxicity and tissue reactivity and had strength testing comparable to that of conventional prostheses [ 112 ]. Huang et al printed a custom-designed surgical guide to optimize the placement of titanium osseointegrated implants for retention of an orbital prosthesis [ 114 ].…”