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Endotoxins in ophthalmic viscosurgical devices
H Burkhard Dick1, A J Augustin, T Pakula
1Department of Ophthalmology, Johannes Gutenberg University of Mainz, Germany. bdick@mail.uni-mainz.de
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, Amvisc Plus, Biolon, Coatel, Healon, Healon GV, Healon, HPMC Ophtal L, Microvisc, Microvisc Plus, Ocucoat, Provisc, Rayvisc, Viscoat, Visco Shield 2%, Visko 1.4%) had an EC under 1.2 endotoxin units/mL, five (Adatocel, HPMC Ophtal H, LA Gel, Viscorneal, Viscorneal Plus) had an EC > or = 1.2 and < or = 24 EU/ml, and four (Biocorneal, Dispasan also named Ophthalin, Dispasan Plus, Visko 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).