Dataset Information

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.

ABSTRACT: Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzyme-based Limulus amebocyte lysate (LAL) assay cannot be applied. Here we propose a rapid and high throughput ambient ionization mass spectrometric (MS) method using direct analysis in real time (DART) for the evaluation of endotoxin contamination in medical device materials. Large and structurally complex endotoxin instantaneously breaks down into low-mass characteristic fragment ions using DART and is detected by MS in both positive and negative ion modes. This method enables the identification and separation of endotoxin from medical materials with a detection limit of 0.03 ng mL-1 endotoxins in aqueous solution. Ophthalmic viscosurgical device materials including sodium hyaluronate (NaHA), non-water soluble perfluoro-n-octane (PFO) and silicone oil (SO) were spiked with different known concentrations of endotoxin and analyzed by DART MS, where the presence of endotoxin was successfully detected and featured small mass fragment ions were generated for NaHA, PFO and SO as well. Current findings showed the feasibility of measuring endotoxin contamination in medical device materials using DART-MS, which can lead to a one-step analysis of endotoxins in different matrices, avoiding any potential contamination during sample pre-treatment steps.

SUBMITTER: Li H

PROVIDER: S-EPMC5500980 | biostudies-literature | 2016 Nov

REPOSITORIES: biostudies-literature

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Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.

Li Hongli H Hitchins Victoria M VM Wickramasekara Samanthi S

Analytica chimica acta 20160929

Bacterial endotoxins are lipopolysaccharides bound to the bacterial cell wall and released when bacteria rupture or disintegrate. Possible contamination of endotoxin in ophthalmic devices can cause a painful eye inflammation or result in toxic anterior segment syndrome after cataract surgery. Measurement of bacterial endotoxin in medical device materials is difficult since endotoxin binds with polymer matrix and some of the materials are very viscous and non-water soluble, where traditional enzy ...[more]

PMID: 27769383

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Project description:Purpose:To assess the efficacy and safety of a novel ophthalmic viscosurgical device-free (OVD-free) method for posterior chamber phakic intraocular lens (PIOL) implantation in myopic eyes. Methods:In this retrospective cohort study, the medical records of myopic eyes that underwent PIOL (Implantable Collamer Lens, ICL) implantation for myopia correction at the Eye Hospital of Wenzhou Medical University between May 2015 and March 2017 were reviewed. A total of 49 eyes with complete data that met follow up requirements (2?h, 1?day, 1?week, 3?months postoperatively) were recruited. Based on the surgical techniques used, the eyes were divided into the OVD-free method group and the standard method group. The clinical data, including intraocular pressure (IOP), corrected distance visual acuity (CDVA) and spherical equivalent (SE), at each follow-up were collected for comparison. Endothelial cell loss and complications were also investigated. Results:Twenty-one eyes received the standard method, and 28 eyes received the OVD-free method. A rise in IOP >?22?mmHg at 2?h was noted in 14 eyes (66.7%) in the standard group and none (0%) in the OVD-free group (p?<?0.001). The rise in IOP from baseline was significantly higher at 2?h in the standard group (10.5?±?5.2?mmHg vs. 2.2?±?3.3?mmHg, difference: 8.3, 95% CI 5.8 to 10.8; p <?0.001). There was a significant difference in the time course of LogMAR CDVA changes between the two groups (p?=?0.047). The LogMAR CDVA was significantly better in the OVD-free method group compared to the standard group at 1?day (-?0.076, 95% CI -?0.134 to -?0.018; p?=?0.012), 1?week (-?0.071, 95% CI -?0.135 to -?0.007; p?=?0.03), but not at 3?months (-?0.046, 95% CI -?0.107 to 0.015; p?=?0.134). There was no significant difference in the time course of SE changes between the two groups (p?=?0.471; p?=?0.705). In the OVD-free group, mean endothelial cell loss was 4.6% at 3?months (2522?±?281 vs. 2407?±?226 cells/mm2, difference: -115, 95% CI -?295 to 65; p?=?0.187). No complications were reported in both groups except for the early IOP elevation in the standard group during the observation period. Conclusions:The OVD-free method is safe and efficient for ICL implantation. It can be a safer method of ICL implantation compared to the standard method in that it completely eliminates ophthalmic viscoelastic devices-related complications without causing additional complications.

Dataset Information

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.

Publications

Rapid detection of bacterial endotoxins in ophthalmic viscosurgical device materials by direct analysis in real time mass spectrometry.

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