Structural and Computational Validation of a Novel Titanium Scleral Buckle Implant for Posterior Pole Retinal Detachment

Background: A novel titanium scleral buckle implant (TSBI) was developed for the treatment of posterior pole retinal detachments, analytically modeled and structurally tested as part of preclinical approval studies. The strength and stiffness requirements to apply pressure for retinal reattachment also suggested potential benefits for correcting high myopia greater than 8 diopters. Methods: Laboratory load testing and analytical calculations were complemented by nonlinear finite element modeling (FEM), applied for the first time to capture the interaction between the highly deformed myopic eye and the TSBI. Simulations were used to visualize posterior pole indentation and force distribution across anatomical regions. Seven TSBI units were tested in the transverse direction and six in the longitudinal direction. Results: The simulations confirmed that stable indentation is maintained even in areas distant from the sutures. The TSBI’s minimum midspan bending capacity was 40 N at yield and 60 N at ultimate. These values, together with FEM predictions, demonstrated a very large safety margin and showed that the implant deforms insignificantly under high intraocular pressure changes. Conclusions: The TSBI withstands ocular forces, cushions the sclera safely, and retains its geometry, a behavior that may differ from softer buckle materials, which can exhibit time-dependent deformation under sustained loading. Early controlled clinical applications outside the USA, followed for over three years, further validate its safety and potential effectiveness.