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Simulated clinical trials in corneal surgery: virtual clinical trials

Poster Details

First Author: H.Studer SWITZERLAND

Co Author(s):    C. Roberts                    

Abstract Details

Purpose:

To propose virtual clinical trials to decrease patients’ risks in trials of new corneal surgical procedures, to reduce or prevent iterations in research and development, and to shorten surgical or diagnostic device time to market.

Setting:

Integrated Scientific Services, Switzerland; The Ohio State University, USA.

Methods:

Finite element biomechanical modeling of the human cornea was used to perform simulations of corneal inlay implantation surgery, laser assisted in-situ keratomileusis surgery, cataract surgery, keratoconus ring-segment implantation surgery, arcuate keratotomy surgery, and corneal cross-linking surgery. The biomechanical description of the human cornea accounted for non-linearity, collagen-fiber distribution, incompressibility, and inhomogeneity over corneal thickness profile. For each case, models were constructed based on patient-specific corneal topography, and post-operative topography was used to validate model performance.

Results:

Our results showed that finite element models are capable of mimicking various types of corneal surgical treatments, including both incisional surgery as well as procedures that involve corneal implants. Furthermore, the simulated post-surgical corneal shape closely reproduced clinical results in terms of central curvature and astigmatism, as well as higher order aberrations. Surgical parameters can be altered in the model, without risk to the patient, in order to optimize surgical approach.

Conclusions:

Finite element biomechanical modeling of the human cornea can be applied to surgical procedures, such as laser refractive surgery, corneal inlays, ring-segment implantation and collagen cross-linking. Such technology has potential for reducing iterations of clinical trials, and might augment bench and animal testing during premarket evaluation of new devices.

Financial Disclosure:

One or more of the authors is employed by a for-profit company with an interest in the subject of the presentation

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