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Histological Biocompatibility of a Stainless Steel Miniature Glaucoma Drainage Device in Humans: A Case Report

¹ Centro di Ricerca Clinica e Laboratorio per il Glaucoma e la Cornea, Di.N.O.G., Clinica Oculistica, University of Genova, Italy
² Charles River Laboratories, Pathology Associates, Frederick, MD 21701, USA
³ Department of Pathology, Sackler School of Medicine, Tel Aviv University 69978, Tel Aviv, Israel and Consultant in Toxicologic Pathology, Timrat, Israel
⁴ Fondazione Banca degli Occhi Melvin Jones, Genova, Italy

Correspondence: Professor Carlo Enrico Traverso, Director of Glaucoma Service, Centro di Ricerca Clinica e Laboratorio per il Glaucoma e la Cornea, Di.N.O.G., Clinica Oculistica, University of Genova, Italy; phone: +39 103538468; fax: +39 1035338295; e-mail:mc8620{at}mclink.it.

The purpose of this study was to evaluate the histological biocompatibility of a stainless steel miniature glaucoma drainage device. Twenty-four months before death due to heart failure, this seventy-three-year-old female patient underwent filtration surgery for primary open-angle glaucoma uncontrolled in the right eye. The device was implanted at the limbus under a scleral flap. For histopathological evaluation, two corneoscleral specimens were embedded in methacrylate blocks sectioned to a thickness of 50 microns, polished and stained with periodic acid schiff. Some sections included a longitudinal cross-section of the implant. At the interface between the spur and the flange of the device and the cornea, there was a small shoulder of fibrous tissue. A thin, fibrous capsule covered the remainder of the body of the device up to the distal tip. No inflammatory cells occurred within the fibrous capsule. No material or blockage was noted within the lumen. Our results support the biological inertness of the device.

Key Words: stainless steel implant • glaucoma filtering surgery • intraocular pressure (IOP) • biocompatibility

Abbreviations: APL, Goldmann Applanation Tonometry; • CFR, Code of Federal Regulations; • FDA, Food and Drug Administration; • IOP, intraocular pressure; • MMA, methyl methacrylate; • PAI, Pathology Associates International Charles River Laboratories; • PAS, periodic acid Schiff; • POAG, primary open-angle glaucoma; • SOPs, standard operating procedures.

Toxicologic Pathology, Vol. 37, No. 4, 512-516 (2009)
DOI: 10.1177/0192623309336150


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