AlphaCor Artificial Cornea

Clinical Outcome

N Jirásková; P Rozsival; M Burova; M Kalfertova

Disclosures

Eye. 2011;25(9):1138-1146. 

In This Article

Abstract and Introduction

Abstract

Purpose The purpose of this study was to describe the long-term results of AlphaCor implantations, and to evaluate the main complications and risk factors.
Methods Retrospective analysis of preoperative and follow-up data from 15 AlphaCor implantations. Analysis of outcomes, trends, and associations was performed and compared with data from published clinical trials and a literature review.
Results The survival rate of the device at 1, 2, and 3 years was 87%, 58%, and 42%, respectively. Postoperative visual acuity ranged from hand movement to 0.8. The most significant complications were stromal melt (nine cases), optic deposition (three eyes), and retroprosthetic membrane formation (three eyes). The most common device-unrelated complication was trauma (three patients). All complications were managed without loss of the eye.
Conclusion AlphaCor provides a treatment option for patients with corneal blindness in which a donor tissue graft would not succeed.

Introduction

AlphaCor is a synthetic cornea made from poly(2-hydroxyethyl methacrylate) that has a peripheral region with interconnecting pores allowing biointegration with surrounding corneal tissue.[1,2] The two concentric regions are joined by means of an interpenetration of polymers across a junctional zone known as the interpenetrating polymer network (IPN).[3] The entire device has a diameter of 7.0 mm, a thickness of 0.6 mm, and surface curvatures that result in appropriate refractive power when implanted. The device is presently available in two powers: AlphaCor-A (for aphakic patients) and AlphaCor-P (for phakic or pseudophakic patients). It is placed within a lamellar corneal pocket with tissue posterior to the optic being removed at the time of implantation (stage I surgery) and the tissue anterior to the optic being removed secondarily (stage II surgery).[1,2,4] The porous skirt remains enclosed within the corneal stromal tissue with which it biointegrates because of cellular colonization and collagen deposition.

AlphaCor is the result of many years of laboratory and clinical research.[5–20] Several complications, associations, and risk factors have been identified.[21–25] The indications and surgical techniques have been evolving with experience.[26,27]

This study aims to evaluate the long-term results, the main complications, and risk factors of AlphaCor implantations.

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