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Endotoxins in ophthalmic viscosurgical devices


Pakula,  Tadeusz
MPI for Polymer Research, Max Planck Society;

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Dick, H. B., Augustin, A. J., Pakula, T., & Pfeiffer, N. (2003). Endotoxins in ophthalmic viscosurgical devices. European Journal of Ophthalmology, 13(2), 176-184.

PURPOSE. To measure the endotoxin concentration (EC) of 25 commercially available, hyaluronic acid- and hydroxypropylmethylcellulose-based (HPMC) ophthalmic viscosurgical devices (OVDs). METHODS. The in vitro Limulus amebocyte lysate (LAL) assay, which indicates the presence of endotoxins originating from gram-negative bacteria, was used to determine the EC. The procedure was performed according to the European Pharmacopoeia/USP. EC including duplicate determinations, negative controls, dilution series with control standard endotoxin, dilution series with sample extract and positive sample control. RESULTS. 16 OVDs (Amvisc(R), Amvisc(R) Plus, Biolon(R), Coatel(R), Healon(R), Healon(R) GV, Healon(R)5, HPMC Ophtal(R) L, Microvisc(R), Microvisc(R) Plus, Ocucoat(R), Provisc(R), Rayvisc(R), Viscoat(R), Visco Shield(R) 2%, Visko(R) 1.4%) had an EC under 1.2 endotoxin units/mL, five (Adatocel(R), HPMC Ophtal(R) H, LA Gel(R), Viscorneal(R), Viscorneal(R) Plus) had an EC greater than or equal to 1.2 and less than or equal to 24 EU/ml, and four (Biocorneal(R), Dispasan(R) also named Ophthalin, Dispasan(R) Plus, Visko(R), 1%) had an EC of > 24 EU/ml. DISCUSSION. To avoid viscoelastic- related inflammatory or immunological reactions, the use of pure OVDs is recommended, especially for surgical procedures with an inherent possibility of leaving viscoelastic remnants in the eye (e.g., cataract surgery, visco-canalostomy or penetrating keratoplasty).