Abstract
Purpose :
Commercialization of 3D printing and a variety of biocompatible printable materials have broadened manufacturing to non-traditional manufacturing settings. Illuminated scleral depressors enable unassisted peripheral vitrectomy but are inconsistently available to all surgical operating systems. We developed customizable illuminated scleral depressors with different optical profiles for ophthalmic surgery. We produced devices compatible with all surgical vitrectomy machines that currently lack commercial options.
Methods :
Computer-aided design (CAD) was used to design three illuminated scleral depressors with customized tips to modify the resulting light beam shape including cylindrical, spherical, and curved tips (Solidworks, Waltham, MA). After iterations, the finalized designs were printed using the Form 3B machine in BioMed Clear Resin, a surgical grade material ISO standard cleared for extended mucosal contact (Formlabs, Somerville, MA). Post-processing included washing, centrifugation, and curing. Sterilization was performed by steam autoclave at 134 oC for 20 minutes. To evaluate mechanical safety and performance, practical testing was conducted by using each 3D printed scleral depressor to indent a porcine eye sclera one hundred times using forces similar to clinical and surgical scleral depression.
Results :
Three illuminated scleral depressors with customized light shapes were 3D printed and tested on porcine eyes. The three devices properly fit the 23G Bausch and Lomb fiberoptic light probe and transmitted light with little attenuation. All three designs produced using biocompatible polymer retained normal structure after sterilization and passed practical testing without structural failure for one hundred trials per device.
Conclusions :
We demonstrated the potential for commercial 3D printing extraocular instruments in ophthalmic surgery. We rapidly prototyped, produced, and tested multiple versions of an instrument for use with a conventional surgical device manufacturer that otherwise lacked a commercially available option. This practical feasibility for using 3D printing to meet needs or existing gaps in ophthalmic surgery. Further clarification of regulatory steps needed to implement real-world application must be expedited to achieve this potential.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.