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1.
Ophthalmologe ; 112(2): 127-39, 2015 Feb.
Artigo em Alemão | MEDLINE | ID: mdl-25536956

RESUMO

BACKGROUND: To test the interchangeability of the commercially available (in Germany) latanoprost drugs and their generics respectively, the concentration of the active substance was tested. Guidelines of the European Medicines Agency postulate a sufficient bioequivalence, if the range of the agent is within 80-125% of the original drug. METHODS: All compounds of latanoprost were procured registered. The concentration of latanoprost and benzalkoniumchloride was measured by high-performance liquid chromatography (HPLC) in a validated reference labroratory for 23 generics. In addition, the mean volume of drops and the pH of the formulation were measured. The packaging label and the readability of the enclosed information leaflet were checked. RESULTS: All products contained less than 50 µg/ml latanoprost. The deviating reduction of the active substance (mean: - 7.39%, ± 2.8%) was accompanied by fluctions of the eyedrops' mass (mean: 0.03 g, ± 0.002 g). The concentration of benzalkonium chloride was mostly increased (median: 5.45%, min: - 2.5%, max: 11.5%). The pH of the original drug and the generics (median 6.78, min: 6.62, max: 6.81) was similar to the original drug, but was significantly different from an unpreserved formulation (pH 7.18). Due to type size, the packaging leaflet was illegible for humans with impaired vision. CONCLUSIONS: Before prescribing generics in ophthalmology, different factors have to be considered, which might influence the amount of IOP lowering in effect. In the absence of healthcare research it is still unclear, how different bottle forms of eyedrops--such as appearance (e.g. Cyrillic characters) or pressure point (administration)--reduce the adherence of glaucoma patients.


Assuntos
Avaliação Pré-Clínica de Medicamentos , Rotulagem de Medicamentos/classificação , Medicamentos Genéricos/análise , Medicamentos Genéricos/química , Prostaglandinas F Sintéticas/análise , Prostaglandinas F Sintéticas/química , Anti-Hipertensivos/análise , Anti-Hipertensivos/química , Alemanha , Latanoprosta , Equivalência Terapêutica
2.
Klin Monbl Augenheilkd ; 231(3): 222-31, 2014 Mar.
Artigo em Alemão | MEDLINE | ID: mdl-24658859

RESUMO

Different strategies for the treatment of inherited photoreceptor degeneration are currently being investigated, with each of these approaches facing specific challenges. Gene therapy, for instance, may be feasible only for genetically well-defined pathologies. However, inherited retinal disorders are genetically highly heterogeneous and early onset disorders may restrict the therapeutic window. The majority of currently developed molecular approaches aim at the reconstitution of physiologically important functions in RPE and photoreceptor. Neuroprotection attempts to prolong cell survival and proper function via sustained delivery systems that fulfil a long-term dynamic reservoir function for therapeutic neuroprotective compounds. Cell-based approaches include replacement strategies such as cell transplantation, the implantation of prosthetic devices or optogenetics. They aim at replacing lost neurosensory functions of the retina. This short review aims at providing an insight into current therapeutic strategies and future treatment options for retinal disorders. Pharmacological and nutritional support strategies are only briefly discussed as we focus here on molecular and prosthetic therapeutic approaches.


Assuntos
Terapia por Estimulação Elétrica/métodos , Terapia Genética/métodos , Terapia de Alvo Molecular/métodos , Fármacos Neuroprotetores/uso terapêutico , Degeneração Retiniana/genética , Degeneração Retiniana/terapia , Transplante de Células-Tronco/métodos , Terapia Combinada/instrumentação , Terapia Combinada/métodos , Humanos , Próteses e Implantes , Degeneração Retiniana/diagnóstico
3.
Klin Monbl Augenheilkd ; 230(12): 1238-46, 2013 Dec.
Artigo em Alemão | MEDLINE | ID: mdl-24104960

RESUMO

BACKGROUND: For an implemented ophthalmological screening within a German long-term cohort study (National Cohort) simple and effective methods for an examination of visual acuity and for non-mydriatic retina photografies should be evaluated. Furthermore standard operating-procedures (SOP) should be developed. METHODS: In the years 2011 and 2012 pinhole visual acuity measurements and automated retina photographies (DRS, CenterVue S. p. a., Padua, Italy) were made at three different epidemiological study centers within Germany. Furthermore, anterior segment images were taken by the camera. Standard operating procedures (SOP) regarding the ophthalmological screening were developed and evaluated within the study. The main question was whether it is possible to implement the screening methods within the National Cohort. Further main outcomes were quality and interpretability of the taken images. RESULTS: 457 subjects (914 eyes) were examined within the investigation. Median VA was 0.8 for right and left eyes (p > 0.42). Image quality of the photographies was good in 491 cases (54 %), fair in 239 cases (26 %) and bad in 179 cases (20 %). The usability of the images was without limitations in 686 cases (75 %), limited in 152 cases (17 %) and not given in 71 cases (8 %). Increasing age of the subjects was slightly correlated with decreasing image quality (r = 0.26) and decreasing image usability (r = 0.2). Anterior segment photographies were usable in 176 eyes (56 %). CONCLUSION: The developed screening method fulfilled the specifications of the National Cohort. The used pinhole visual acuity examination was fast and cheap. Image quality and usability of the retina photographies could be improved with prolonged pupil recovery times. The quality of the anterior segment images could not fulfill the expectations and were taken out of the further examinations of the ophthalmological screening. The written SOP showed good acceptance within the investigators' daily routine. The ophthalmological screening within the National Cohort generates information (e. g., pathologies of the vessels or of the retina) which are useful not only from an ophthalmological point of view.


Assuntos
Custos de Cuidados de Saúde/estatística & dados numéricos , Programas de Rastreamento/economia , Retinoscopia/economia , Transtornos da Visão/diagnóstico , Transtornos da Visão/economia , Testes Visuais/economia , Adulto , Idoso , Estudos de Coortes , Análise Custo-Benefício , Feminino , Alemanha , Humanos , Masculino , Programas de Rastreamento/métodos , Pessoa de Meia-Idade , Programas Nacionais de Saúde/economia , Projetos Piloto , Reprodutibilidade dos Testes , Retinoscopia/métodos , Sensibilidade e Especificidade , Transtornos da Visão/prevenção & controle , Testes Visuais/métodos , Adulto Jovem
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