Purpose: To report histologic findings in 14 AlphaCor artificial corneas implanted during clinical trials and subsequently explanted from human subjects following complications, so as to evaluate biointegration within the device skirt.
Methods: Explants were fixed and sectioned in paraffin. Histologic findings related to the device skirt were compared with earlier histologic results from animal studies and correlated with clinical histories.
Results: Two devices had been removed due to complications related to the optic alone, 11 following stromal melting overlying the biointegratable sponge skirt and 1 due to a retroprosthetic membrane. All devices demonstrated normal skirt porosity. Biointegration was similar to that found in animal studies but qualitatively appeared reduced in the affected areas in patients with overlying stromal melting prior to explantation. Patients with a longer history of melting prior to explantation demonstrated presence of inflammatory cells around the device.
Conclusions: Histologic findings of the AlphaCor skirt in humans are consistent with earlier animal studies. This study confirms that biointegration by host fibroblastic cells, with collagen deposition occurs after AlphaCor implantation in humans. In cases in which stromal melting had occurred, biointegration is seen to be reduced. On correlating preoperative clinical factors with biointegration observed histologically, preoperative vascularization appears not to be required for AlphaCor biointegration.
From the *Biomaterials Research Centre, Lions Eye Institute, University of Western Australia, Nedlands, Western Australia, Australia; and †John A. Moran Eye Center, University of Utah, Salt Lake City, Utah.
Received for publication June 10, 2004; revision received February 11, 2005; accepted February 11, 2005.
The clinical study during which devices were implanted was supported by the National Health and Medical Research Council, Australia. The Biomaterials Research Centre and the John A. Moran Eye Center receive research funding from CooperVision Surgical, Perth, Australia, toward histologic examination of devices.
Dr. Hicks has a financial interest in CooperVision Surgical in the form of support of departmental funding, travel, and research.
Reprints: C.R. Hicks, Lions Eye Institute, 2 Verdun Street, Nedlands, WA, 6009, Western Australia, Australia (e-mail: email@example.com).