Safety and efficacy of subretinal visual implants in humans: methodological aspects

Replacing the function of visual pathway neurons by electronic implants is a novel approach presently explored by various groups in basic research and clinical trials. The novelty raises unexplored methodological aspects of clinical trial design that may require adaptation and validation.

[1]  A. Milam,et al.  Histopathology of the human retina in retinitis pigmentosa. , 1998, Progress in retinal and eye research.

[2]  Eberhart Zrenner,et al.  Phosphenes electrically evoked with DTL electrodes: a study in patients with retinitis pigmentosa, glaucoma, and homonymous visual field loss and normal subjects. , 2006, Investigative ophthalmology & visual science.

[3]  E. Zrenner,et al.  Long-term survival of retinal cell cultures on retinal implant materials , 1999, Vision Research.

[4]  Douglas Carnall,et al.  Death and dying , 2000, BMJ : British Medical Journal.

[5]  Michael Bach,et al.  Basic quantitative assessment of visual performance in patients with very low vision. , 2010, Investigative ophthalmology & visual science.

[6]  J. Vance.  A degree of vision , 2000, The Lancet.

[7]  D. Stager,et al.  The Teller Acuity Cards Are Effective in Detecting Amblyopia , 2008, Optometry and vision science : official publication of the American Academy of Optometry.

[8]  [Psycho-affective problems associated with retinitis pigmentosa]. , 1997, Journal francais d'ophtalmologie.

[9]  Eberhart Zrenner,et al.  Studies on the feasibility of a subretinal visual prosthesis: data from Yucatan micropig and rabbit , 2001, Graefe's Archive for Clinical and Experimental Ophthalmology.

[10]  Eberhart Zrenner,et al.  Solar cells for the blind , 2012, Nature Photonics.

[11]  D Besch,et al.  [What can blind patients see in daily life with the subretinal Alpha IMS implant? Current overview from the clinical trial in Tübingen]. , 2012, Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft.

[12]  E Zrenner,et al.  [Histological studies of retinal degeneration and biocompatibility of subretinal implants]. , 2001, Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft.

[13]  V. Chowdhury,et al.  Evaluation of patient suitability for a retinal prosthesis using structural and functional tests of inner retinal integrity , 2009, Journal of neural engineering.

[14]  Jean Delbeke,et al.  Measurement of evoked potentials after electrical stimulation of the human optic nerve. , 2010, Investigative ophthalmology & visual science.

[15]  E. Zrenner,et al.  Compound subretinal prostheses with extra-ocular parts designed for human trials: successful long-term implantation in pigs , 2007, Graefe's Archive for Clinical and Experimental Ophthalmology.

[16]  D. Albert,et al.  ADVANCED PIGMENTARY RETINAL DEGENERATION: An Ultrastructural Study , 1982, Retina.

[17]  . Bartz-Schmidt,et al.  Subretinal electronic chips can restore useful visual functions in blind retinitis pigmentosa patients , 2010 .

[18]  E. Zrenner,et al.  Electrical multisite stimulation of the isolated chicken retina , 2000, Vision Research.

[19]  Alfred Stett,et al.  Subretinal electronic chips allow blind patients to read letters and combine them to words , 2010, Proceedings of the Royal Society B: Biological Sciences.

[20]  C. Kufta,et al.  Feasibility of a visual prosthesis for the blind based on intracortical microstimulation of the visual cortex. , 1996, Brain : a journal of neurology.

[21]  Arup Roy,et al.  Factors affecting perceptual thresholds in epiretinal prostheses. , 2008, Investigative ophthalmology & visual science.

[22]  D Besch,et al.  Extraocular surgery for implantation of an active subretinal visual prosthesis with external connections: feasibility and outcome in seven patients , 2008, British Journal of Ophthalmology.

[23]  A. Milam,et al.  Preservation of the inner retina in retinitis pigmentosa. A morphometric analysis. , 1997, Archives of ophthalmology.

[24]  K. Stingl,et al.  Was können blinde Patienten mit dem subretinalen Alpha-IMS-Implantat im Alltag sehen? , 2012, Der Ophthalmologe.

[25]  K. Kohler,et al.  Histologische Untersuchungen zur Netzhautdegeneration und zur Gewebeverträglichkeit subretinaler Implantate , 2001, Der Ophthalmologe.

[26]  E Zrenner,et al.  [Status of the subretinal implant project. An overview]. , 2005, Der Ophthalmologe : Zeitschrift der Deutschen Ophthalmologischen Gesellschaft.

[27]  M. Bach,et al.  Resolving the clinical acuity categories “hand motion” and “counting fingers” using the Freiburg Visual Acuity Test (FrACT) , 2008, Graefe's Archive for Clinical and Experimental Ophthalmology.

[28]  Jessy D. Dorn,et al.  Interim results from the international trial of Second Sight's visual prosthesis. , 2012, Ophthalmology.

[29]  Michael Bach,et al.  The Freiburg Visual Acuity Test-Variability unchanged by post-hoc re-analysis , 2007, Graefe's Archive for Clinical and Experimental Ophthalmology.

[30]  Michael Bach,et al.  Testing Visual Functions in Patients with Visual Prostheses , 2007 .

[31]  F. Gekeler,et al.  Stand des subretinalen Implantatprojekts , 2005, Der Ophthalmologe.

[32]  L. Derogatis,et al.  The Brief Symptom Inventory: an introductory report , 1983, Psychological Medicine.

[33]  E. Zrenner.  Will Retinal Implants Restore Vision ? , 2002 .

[34]  Thomas Schanze,et al.  Visual resolution with retinal implants estimated from recordings in cat visual cortex , 2006, Vision Research.