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Jose D. Luna Pinto, Luciana G. Garcia, Ana L. Gramajo, Valeria Alacino, Juan P. Pusterla, Claudio P. Juarez, Hugo M. Fajreldines, Dante M. Beltramo; Ocular Biocompatibility Of SC230 Celcuat Gel: Functional And Morphological Results. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5678.
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© ARVO (1962-2015); The Authors (2016-present)
The selection of biomaterials to be used as an ophthalmic viscosurgical device (OVD) raise concerned about the physicochemical and optical properties of the substance. OVD have become a valuable tool in anterior segment surgery for space creation, balancing pressure in the anterior and posterior chambers, tissue stabilization, and protection of the corneal endothelial cells. The purpose of this study was to provide a preliminary evaluation of the topical and intraocular biocompatibility, security and toxicity of the cationic hydroxyethylcelluloses polyquaternium-10 (Celcuat SC-230 PQ-10).
Hydrogel synthesis and extrudability test were performed. This last test was made with a TAXT2 texturometer and the extrudability profiles were obtained for Celcuat SC-230 PQ-10 with carbomer as a control. Cytotoxicity assays were evaluated in two cell lines: HEp-2 and VERO (human larynx epidermoid carcinoma cell and African green monkey kidney cells respectively). Eighteen rabbits, divided into three groups of six rabbits each, were used. Their rights eyes were treated with topical, subconjuntival and intraocular 1% SC-230, respectively. Their left eyes served as controls, and were treated with 0.1% hydroxymethylcellulose in the same fashion correspondingly. Clinical, histological and electrophysiological studies were done.
There were no statistically significant differences between treatment groups. No in-vitro cytotoxic activity was seen for Celcuat SC-230 PQ- 10 in any of the cell lines used in this study. Clinical studies did not show any statistical significant signs of ocular inflammation when comparing groups. Normal histological characteristic were seen in both groups with no histological inflammatory reaction. After one month from the intraocular application of SC-230 1% (treatment group) or 0.1% hydroxymethylcellulose (control group), electroretinograms (ERGs) showed similar levels of a- and b-waves latencies and amplitude.
Celcuat SC-230 PQ-10 gel was well tolerated in these experiments. Celcuat SC-230 PQ-10 appears to be a promising biomaterial as a new ophthalmic viscosurgical device, although long-term follow-up is necessary.
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