ABSTRACT
BACKGROUND: The prevalence of blindness as defined by law could be reduced by the introduction of anti-vascular endothelial growth factor (VEGF) therapy. Because the treatment is governed by patient needs, mostly using morphological criteria, imaging diagnostics are of particular importance. The non-interventional OCEAN study investigates the treatment with ranibizumab in the clinical routine practice. In a subgroup of patients the interpretation of spectral domain optical coherence tomography (SD-OCT) scans by the treating physicians will be analyzed (ORCA module). METHODS: Over a period of 24 months data from patients with exudative age-related macular degeneration (AMD), macular edema due to retinal vein occlusion or diabetes mellitus, who are receiving intravitreal injections of ranibizumab, will be assessed. Information on examinations, visual acuity, treatment and recordings from imaging techniques will be documented using a questionnaire. The SD-OCT scans, fluorescence angiography and fundus photography will be independently analyzed by the ophthalmologist of the study center and by three reading centers (CIRCL Cologne, GRADE Bonn and M3 Münster). Automated measurements of retinal thickness by the manufacturers' software will be checked and if necessary manually corrected. A qualitative interpretation in terms of morphological criteria for (further) treatment will be performed. CONCLUSION: A thorough assessment of SD-OCT images during anti-VEGF therapy provides the basis for the best possible needs-oriented treatment regimen. The control of the quality of data from daily routine practice may indicate possible weaknesses allowing explicit training and therefore optimization of patient treatment.
Subject(s)
Blindness/diagnosis , Blindness/drug therapy , Ranibizumab/therapeutic use , Tomography, Optical Coherence , Vascular Endothelial Growth Factor A/antagonists & inhibitors , Blindness/epidemiology , Blindness/etiology , Diabetic Retinopathy/diagnosis , Diabetic Retinopathy/drug therapy , Fluorescein Angiography , Germany , Humans , Intravitreal Injections , Macular Degeneration/complications , Macular Degeneration/diagnosis , Macular Degeneration/drug therapy , Macular Edema/complications , Macular Edema/diagnosis , Macular Edema/drug therapy , Quality Assurance, Health Care , Retina/drug effects , Retinal Vein Occlusion/complications , Retinal Vein Occlusion/diagnosis , Retinal Vein Occlusion/drug therapy , Surveys and Questionnaires , Treatment OutcomeABSTRACT
Pre-clinical in vitro tests are needed to evaluate the biomechanical performance of new spinal implants. For such experiments large animal models are frequently used. Whether these models allow any conclusions concerning the implant's performance in humans is difficult to answer. The aim of the present study was to investigate whether calf, pig or sheep spine specimens may be used to replace human specimens in in vitro flexibility and cyclic loading tests with two different implant types. First, a dynamic and a rigid fixator were tested using six human, six calf, six pig and six sheep thoracolumbar spine specimens. Standard flexibility tests were carried out in a spine tester in flexion/extension, lateral bending and axial rotation in the intact state, after nucleotomy and after implantation. Then, the Coflex interspinous implant was tested for flexibility and intradiscal pressure using another six human and six calf lumbar spine segments. Loading was carried out as described above in the intact condition, after creation of a defect and after implantation. The fixators were most easily implantable into the calf. Qualitatively, they had similar effects on ROM in all species, however, the degree of stability achieved differed. Especially in axial rotation, the ROM of sheep, pig and calf was partially less than half the human ROM. Similarly, implantation of the Coflex interspinous implant caused the ROM to either increase in both species or to decrease in both of them, however, quantitatively, differences were observed. This was also the case for the intradiscal pressure. In conclusion, animal species, especially the calf, may be used to get a first idea of how a new pedicle screw system or an interspinous implant behaves in in vitro flexibility tests. However, the effects on ROM and intradiscal pressure have to be expected to differ in magnitude between animal and human. Therefore, the last step in pre-clinical implant testing should always be an experiment with human specimens.
Subject(s)
Cattle/physiology , Models, Biological , Prostheses and Implants , Sheep/physiology , Spine/physiology , Sus scrofa/physiology , Adult , Animals , Biomechanical Phenomena , Cattle/anatomy & histology , Humans , Intervertebral Disc/anatomy & histology , Intervertebral Disc/physiology , Middle Aged , Neurosurgical Procedures/instrumentation , Neurosurgical Procedures/methods , Prostheses and Implants/standards , Range of Motion, Articular/physiology , Sheep/anatomy & histology , Spinal Diseases/surgery , Spinal Fusion/instrumentation , Spinal Fusion/methods , Spine/anatomy & histology , Sus scrofa/anatomy & histology , Weight-Bearing/physiologyABSTRACT
For survival of plants, animals as well as main in a nature full of aggressive microbes, endogenous antibiotics play an essential role, which is not yet fully appreciated in medicine and science. For example in the granules of polymorphonuclear granulocytes and macrophages or even of specialized epithelial cells such as Paneth cells in the crypts of the intestinal mucosa, oligopeptides are produced with a wide range of antimicrobial activity. According to their chemical structures and modes of action they can be grouped into various different families. The physiological role of these agents on the surface of skin and mucosa or within host tissue is only incompletely understood.
