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Sonja Rohleder, Yen-An Chen, Nino Hirnschall, Sonja Hoeller, Oliver Findl; Tearfilm Substitution with Viscous Eye Lubricant to Maintain Optical Clarity during Ophthalmic Surgery. Invest. Ophthalmol. Vis. Sci. 2011;52(14):5697.
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The safety and efficacy of corneal epithelial intra-operative protection using a viscous eye lubricant (Corneaprotect, 2% HPMC) on the postoperative corneal epithelial integrity and patient discomfort as well as optical clarity during surgery was assessed in comparison to balanced saline solution (BSS). To this end a randomized, controlled study that was subject- and examiner-masked, was conducted.
The present study followed the tenets of the Helsinki agreement and was approved by the local ethics committee. Randomised eyes of patients with no additional ocular pathologies were subject to cataract surgery under topical anaesthesia. The groups were applied one drop of 2% Corneaprotect gel or BSS, respectively, to the cornea at surgery onset. The application was repeated, if necessary for continuous irrigation. Surgeons assessed optical clarity (scale 1-5) and application frequency during surgery. An observer, blinded to group allocation, assessed grading of fluorescein staining and the tear film-break up time (BUT) one hour post surgery. Subsequently patients assessed subjective eye discomfort and perception of dry eye.
A total of 101 eyes of 97 patients (age mean: 73.6 yrs; range: 53-87 yrs) were included in the study. Optical clarity during surgery for BSS and for 2% HPMC was 2.0 and 1.0, respectively (statistically significant; p=0.03) and mean application frequency of BSS was 10 fold higher: HPMC 2% had to be applied only once per surgery. Grading of the fluorescein staining, median outcome concerning patient discomfort in the eye and patient perception of dry eye as well as BUT for BSS and HPMC showed no statistically significant differences. No adverse effects were observed during the study.
The study results show that tearfilm substitution with a 2% HPMC-containing viscous eye lubricant is beneficial in terms of optimal surgical conditions. This includes improved optical clarity and reduction of irrigating agent needed: Multiple applications of BSS during surgery can simply be replaced by the once-only one-drop application of Corneaprotect.
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