Predicting the biomechanical stability of IOLs inside the postcataract capsular bag with a finite element model.

BACKGROUND AND OBJECTIVES: Although cataract surgery is a safe operation in developed countries, there is still room for improvement in terms of patient satisfaction. One of the key issues is assessing the biomechanical stability of the IOL within the capsular bag to avoid refractive errors that lead to a second surgery. For that purpose, a numerical model was developed to predict IOL position inside the capsular bag in the short- and long-term. METHODS: A finite element model containing the implanted IOL, the postcataract capsular bag, the zonules, and a portion of the ciliary body was designed. The C-loop hydrophobic LUCIA IOL was used to validate the numerical model and two more worldwide IOL designs were tested: the double C-loop hydrophobic POD FT IOL and the plate hydrophilic AT LISA IOL. To analyze the biomechanical stability in the long-term, the effect of the fusion footprint, which occurs days following cataract surgery, was simulated. Moreover, several scenarios were analyzed: the size and location of the capsulorexhis, the capsular bag diameter, the initial geometry of the capsular bag, and the material properties of the bag. RESULTS: The biomechanical stability of the LUCIA IOL was simulated and successfully compared with the in vitro results. The plate AT LISA design deformed the capsular bag diameter up to 11.0 mm against 10.5 mm for the other designs. This design presented higher axial displacement and lower rotation, 0.19 mm and 0.2∘, than the C-loop design, 0.09 mm and 0.9∘. CONCLUSIONS: All optomechanical biomarkers were optimal, assuring good optical performance of the three IOLs under investigation. Our findings showed that the capsulorexhis size influences the stiffness of the capsular bag; however, the shape in the anterior and posterior curvature surfaces of the bag barely affect. The results also suggested that the IOL is prone to mechanical perturbations with the fusion footprint, but they were not high enough to produce a significant refractive error. The proposed model could be a breakthrough in the selection of haptic design according to patient criteria.

Mechanical characterisation of hydrophobic and hydrophilic acrylates used in intraocular lenses through depth sensing indentation.

In this work, the mechanical behaviour of hydrophilic and hydrophobic acrylates has been characterised by depth sensing indentation. Time-dependent behaviour has been studied using load-relaxation tests. Experiments have been simulated with a finite element software using a visco-hyperelastic material model. The parameters of this model have been determined using deep learning techniques. The developed material models have been used to mechanically simulate a standard compression test of a prototype intraocular lens.

Experimental evaluation of the injection force exerted in intraocular lens delivery with syringe-type injectors.

The process of intraocular lens (IOL) delivery within the capsular bag during cataract surgery is crucial, as the integrity of the IOL, the injector and the ocular structures should be preserved at all times. This study aims to obtain the main parameters that affect the injection force exerted in the ejection of an intraocular lens (IOL) through syringe-type injectors. For that purpose, ejection tests were carried out in vitro, measuring the resistance force throughout the entire delivery process. The effect of IOL material, haptic design, IOL thickest area and ophthalmic viscosurgical device (OVD) was studied by ejecting seven IOLs with four syringe-type injectors of different sizes, 3.0, 2.2 and 1.8 mm. In all injectors, plate hydrophilic IOLs present the lowest resistance forces; hydrated C-loop hydrophobic IOLs present higher forces and the C-loop hydrophobic IOL in dry conditions presents the highest resistance forces. All IOLs could be properly delivered with an injector size of 2.2 mm, making injector sizes of 3.0 mm outdated. The injector size of 1.8 mm damaged several IOLs. IOL material and cartridge nozzle size were the most influential parameters in IOL delivery. IOL thickest area was also relevant but in a lesser extent whereas IOL haptic design was not as relevant.

A numerical investigation of changes in lens shape during accommodation.

The purpose of this study was to investigate how the mechanical properties and geometry of the lens influence the changes in lens shape during accommodation. To do so, ex vivo stretching tests of the isolated lens were simulated via finite element analysis. In these tests, the lens is stretched from the accommodated state to the non-accommodated state. Several key characteristics of the lens were studied: the stiffness gradient of the lens material, the distribution of the capsule thickness, the mechanical properties of the capsule and the material comprising the lens, nucleus and cortex, and the influence of two different age-related lens geometries (17 and 29 y/o subjects). To determine the effects on the changes in lens shape during accommodation, changes in the anterior and posterior radius, the lens and nucleus thicknesses and the equatorial lens diameter were analysed. The results suggest that multiple factors exert statistically significant influences on how the lens changes its shape, but two factors predominate over the rest: the stiffness ratio between the nucleus and cortex and the stiffness of the capsule, specifically the posterior surface.

Effect of haptic geometry in C-loop intraocular lenses on optical quality.

The biomechanical stability of intraocular lenses (IOLs) must achieve high-quality optical performance and clinical outcomes after cataract surgery. For this reason, the quality and performance features of the IOLs should be previously analysed following the Standard ISO 11979-2 and ISO 11979-3. The ISO 11979-3 tries to reproduce the behaviour of the IOL in the capsular bag by compressing the lens between two clamps. With this test, it has been demonstrated that the haptic design is a crucial factor to obtain biomechanical stability. Hence, the main goal of this study was to design an aberration-free aspheric IOL and to study the influence of haptic geometry on the optical quality. For that purpose, 5 hydrophobic IOLs with different haptic design were manufactured and their biomechanical stability was compared experimentally and numerically. The IOLs were classified as stiff and flexible designs depending on their haptic geometry. The biomechanical response was measured by means of the compression force, the axial displacement, the angle of contact or contact area, the decentration, the tilt and the strain energy. The results suggest that in vitro and in silico compression tests present similar responses for the IOLs analysed. Furthermore, the flexible IOL designs presented better biomechanical stability than stiff designs. These results were correlated with the optical performance, where the optical quality decreases with worst biomechanical stability. This numerical methodology provides an indisputable advance regarding IOL designs, leading to reduce costs by exploring a feasible space of solutions during the product design process and prior to manufacturing.

Customised Selection of the Haptic Design in C-Loop Intraocular Lenses Based on Deep Learning.

In order to increase the probability of having a successful cataract post-surgery, the customisation of the haptic design of the intraocular lens (IOL) according to the characteristics of the patient is recommended. In this study, we present two prediction models based on deep neural networks (DNNs). One is capable of predicting the biomechanical stability of any C-loop IOL, whereas the other can predict the haptic design that fits a desired biomechanical response, enabling the selection of the optimal IOL as a function of the IOL diameter compression. The data used to feed the networks has been obtained from a validated finite element model in which multitude of geometries are tested according to the ISO 11979-3 compression test, a standard for the mechanical properties of the IOLs. The biomechanical response model provides a very high accurate response (Pearson's r = 0.995), whilst the IOL haptic design model shows that several IOL designs can provide the same biomechanical response (Pearson's r = 0.992). This study might help manufacturers and ophthalmologists both analyse any IOL design and select the best IOL for each patient. In order to facilitate its application, a graphical user interface (GUI) was created to show the potential of deep learning methods in cataract surgery.

Systematic Study on the Biomechanical Stability of C-Loop Intraocular Lenses: Approach to an Optimal Design of the Haptics.

To study the main design parameters that affect the mechanical stability of C-loop intraocular lenses, leading to an optimal design that minimizes the axial displacement, tilt and rotation. A total of 144 geometrical variations were studied on a 1-piece, non-angulated, C-loop hydrophobic acrylate intraocular lens. The study was performed in a finite element modeling simulation. The suitable set of variations was determined using a mixed-factorial analysis, allowing to analyse the impact of the different designs on the mechanical stability of the lens (compression force, axial displacement, tilt and rotation). The design parameters under study were: the length, width, thickness and opening angle of the haptic, the haptic-optic junction and the start of the haptic curvature. The compression (or reaction) force is affected by the haptic width, the haptic-optic junction, and the interaction between both. The axial displacement is mainly affected by the width and thickness of the haptic, and the size of the haptic-optic junction as well. The tilt is affected by the haptic thickness and the interaction between the haptic curvature and the haptic-optic junction. The rotation is affected by the start of the haptic curvature, the haptic-optic junction and the haptic width. The haptic-optic juntion is one of the most influential parameters affecting the four responses studied of the C-Loop IOL. The smaller the haptic-optic juntion, the better biomechanical stability.