[ISO 9001-2000 certification for refractive laser treatment]. / Certification ISO 9001-2000 des traitements réfractifs par laser cornéen.

PURPOSE: To obtain ISO 9001-2000 certification for laser corneal refractive treatment, never before sought in Europe. MATERIAL AND METHODS: The consulting firm Veritas led the certification process with the clinic's staff manager. This ISO norm is dedicated to the implementation of a quality management system. We assessed and optimized all necessary resources, evaluating customer satisfaction using patient and referring-physician surveys. We started quality rounds including surgeons, nurses, and technicians. Based on this preparation, we redefined and explained all processes including staff responsibilities and necessary resources in the quality manual. The procedure lasted 14 months with substantial involvement on the part of the management. RESULTS: Unconditional ISO 9001-2000 certification was granted by the independent audit firm, BVQI, in december 2003 for refractive laser treatment. CONCLUSION: The 2000 version of the new ISO 9001-2000 seeks to meet the demand for improving health care delivery in this field, most particularly by establishing a clear procedural orientation. Such certification enhances team work, stabilizes methodologies, and reinforces cohesion and self-audit. Patients notice that the center follows a consistent quality policy and are assured that the clinic respects rules and regulations. Certification is an advantageous alternative when accreditation cannot be considered. Our article discusses the steps taken in upper management, quality management, procedural guidance, as well as customer and staff counselling. It also discusses the project's cost/benefit ratio for the organization.

[Dynamic viscosity and corneal endothelial protection with Healonid, Healon GV, Provisc and Viscoat during phacoemulsification]. / Viscosite dynamique et protection endotheliale corneenne du Healonid, du Healon GV, du Provisc et du Viscoat au cours de la phacoemulsification.

PURPOSE: To demonstrate the utility of a viscoelastic substance which maintains high viscosity during phacoemulsification, we conducted a double study. METHODS: We compared in vitro the corneal endothelial protection offered by Healon, Healon GV, Provisc and Viscoat after <> phacoemulsification. Eight samples of ten to fifteen freshly enucleated pig eyes were operated; the first four groups were the controls, whereas the other four tested the different viscous solutions. In parallel, we determined the rheologic properties of the four viscoelastic substances in a physicS laboratory. To measure the percentage of corneal endothelial cell damage, we used the Janus Green spectrometric technique. RESULTS: Corneal endothelial cell damage averaged 31.67% in eyes in which no viscoelastic substance was used. Damage was 14.29% in specimens that received Healon, 12.85% with Healon GV, 2.48% in the Viscoat group and 15.43 in those that received Provisc. There is a significant difference (p <0.001) between the Viscoat group and all other samples. The values of the viscosity at different shear rates and the graph of viscosities as a function of shear rate of the four viscous solutions are given. CONCLUSION: Viscoat has a very high dynamic viscosity at high shear rate. This property and a poor cohesion provide a better corneal endothelial protection during in vitro phacoemulsification.

In vitro organotypic culture method to evaluate the biocompatibility of heparin-surface-modified intraocular lenses.

Using an organotypic culture method, we evaluated the biocompatibility of two kinds of intraocular lenses: conventional poly(methyl methacrylate) (PMMA) and heparin-surface-modified (HSM) PMMA. Chicken corneal endothelium from embryos incubated for 14 days was placed on an agar medium and covered with one of three types of materials: PMMA, HSM PMMA, and a control, Thermanox. Experiments at five different times measured cell migration, cell multiplication, and cell adhesion. Scanning electron microscopy showed a low level of corneal endothelial adhesion on the HSM IOL surface. There was a significant difference between the HSM and untreated lenses in migration surface and cell density, with the HSM lenses having better biocompatibility.

Clinical risk factors for proliferative vitreoretinopathy after retinal detachment surgery.

PURPOSE: To identify the clinical risk factors for the development of severe proliferative vitreoretinopathy (PVR) after retinal detachment surgery. METHODS: A retrospective study of 1020 patients with either no PVR or with PVR of grade C1 or less at initial examination was conducted. After surgery, severe PVR was defined as grade C2 or worse. The data relating to 94 variables were evaluated by univariate analysis and stepwise logistic regression. RESULTS: Severe PVR developed after surgery in 107 patients (10.5%). Ten significant predictive variables were identified: minor intra- or postoperative hemorrhage, grade A preoperative PVR, preoperative choroidal detachment, giant tears, air tamponade, detachment involving more than 2 quadrants, cumulative break area larger than 3 optic disks, postoperative choroidal detachment, signs of uveitis at initial examination, and grade B preoperative PVR. CONCLUSION: The results indicate that in addition to the size of breaks, extent of detachment, and presence of preoperative inflammation or low-grade PVR, iatrogenic problems also are important factors in the pathogenesis of severe PVR after surgery for retinal detachment.