Efficient Objective Metric Tool for Medical Electrical Device Development: Eye Phantom for Glaucoma Diagnosis Device

Abstract

Developing electronic medical devices is challenging. Simulations or in vivo experiments are not sufficient to obtain pertinent comparisons between potential design options. This paper presents a new artificial tool allowing objective comparisons between electronic device topologies. The main idea is to build a tool which is sensitive to targeted biological parameters only. These tools are generally called phantoms. The phantom presented in this paper is dedicated to IntraOcular Pressure (IOP) Measurement devices used in glaucoma diagnosis and treatment. It is called Biomechanical Eye Emulator (BEE). The BEE emulates the main biomechanical parameters influencing the IOP measurements. Because it is not sensitive to the living context, the BEE is the most efficient tool to investigate the best sensor design. BEE specifications are defined to be as close as possible to chosen models (humans or animals). Its efficiency is shown with a case study on rabbits. The results clearly demonstrate the BEE phantoms efficacy in providing objective assessment metrics during the sensor design process.

Development of eye phantom for mimicking the deformation of the human cornea accompanied by intraocular pressure alterations

“…Deluthault et al 7 developed a silicone eye phantom similar in shape to a contact lens, and used it to test a glaucoma diagnosis device. The Young’s modulus of the phantom cornea, a measure of its linear elasticity, was approximately 2.5 MPa, which differed from the physiological Young’s modulus of the cornea 15 .…”

“…In addition, the tonometry readings of IOP show that the values from the CEP were overestimated, while those from the FEP were not. For these reasons, we expect that the FEP could be suitable for the estimation of true IOP and allow performance testing of tonometers for medical checkups and other clinical uses.After the introduction of a phantom in the shape of a medication cup to evaluate the performance of artificial silicon vitreous implants 1 , many different types of eye phantoms have been designed to reproduce the characteristics of the human eye to be used for various purposes: prosthetics, surgery simulation 2-4 , and testing and evaluation of diagnostic instruments [5][6][7][8] , such as optical coherence tomography (OCT) machines and tonometers. The shapes of eye phantoms vary according to their purposes.…”

Development of Eye Phantoms for Mimicking the Structural Deformation of the Human Cornea Accompanied With Intraocular Pressure Alteration

“…Eye phantoms, which are designed to reproduce characteristics of the human eye, have been developed for various purposes: prosthetics, surgery simulation [1][2][3] , and testing and evaluation of diagnostic instruments [4][5][6][7] , including the optical coherence tomography (OCT) machine and the tonometer. The shapes of eye phantoms vary with their purposes.…”

“…Hence, it is invaluable to invent an eye phantom to mimic the structural deformation as well as the tension accompanying a change in IOP. Eye phantoms [6][7][8][9] have been developed specifically for mimicking the human cornea. Anthony et al 6 developed an eye phantom used for testing of a glaucoma diagnosis device, that was similar to a contact lens.…”

“…Eye phantoms [6][7][8][9] have been developed specifically for mimicking the human cornea. Anthony et al 6 developed an eye phantom used for testing of a glaucoma diagnosis device, that was similar to a contact lens. The device made of silicone, but Young's modulus of the cornea, a measure of elasticity, was approximately 2.5 MPa, which was quite different from that of human subjects.…”