BACKGROUND: To restore vision in patients with retinitis pigmentosa, several types of electronic devices have been developed to stimulate neurons at different levels along the visual pathway. Subretinal stimulation of the retina with the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) has been demonstrated to provide useful vision in daily life. Here we evaluated the safety of this device. METHODS: An interventional, prospective, multi-center, single-arm study was conducted in patients with retinitis pigmentosa with the Retina Implant Alpha IMS. The results from the first nine patients of a single center regarding safety of the device are reported. Any untoward medical occurrence related or unrelated to the tested device was documented and evaluated. RESULTS: Nine adult subjects were included in the study at the Tübingen site. Seventy-five adverse events occurred in total, and 53 affected the eye and its adnexa. Thirty-one ocular adverse events had a relationship to the implant that was classified as "certain" while 19 had a probable or possible relationship; three had no relationship to the implant. Thirty-nine ocular adverse events resolved without sequelae, two resolved with sequelae, 11 remained unresolved, and in one the status was unknown. The intensity of ocular adverse events was mild in the majority of cases (n = 45), while six were of moderate and two of severe intensity. There was no non-ocular adverse event with certain relationship to the device. One subject lost light perception (without light localization) in her study eye. CONCLUSIONS: In conclusion, this prospective study, "Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients," shows that the Retina Implant Alpha IMS is an option for restoring vision using a subretinal stimulation device with a clinically acceptable safety profile.
BACKGROUND: To restore vision in patients with retinitis pigmentosa, several types of electronic devices have been developed to stimulate neurons at different levels along the visual pathway. Subretinal stimulation of the retina with the Retina Implant Alpha IMS (Retina Implant AG, Reutlingen, Germany) has been demonstrated to provide useful vision in daily life. Here we evaluated the safety of this device. METHODS: An interventional, prospective, multi-center, single-arm study was conducted in patients with retinitis pigmentosa with the Retina Implant Alpha IMS. The results from the first nine patients of a single center regarding safety of the device are reported. Any untoward medical occurrence related or unrelated to the tested device was documented and evaluated. RESULTS: Nine adult subjects were included in the study at the Tübingen site. Seventy-five adverse events occurred in total, and 53 affected the eye and its adnexa. Thirty-one ocular adverse events had a relationship to the implant that was classified as "certain" while 19 had a probable or possible relationship; three had no relationship to the implant. Thirty-nine ocular adverse events resolved without sequelae, two resolved with sequelae, 11 remained unresolved, and in one the status was unknown. The intensity of ocular adverse events was mild in the majority of cases (n = 45), while six were of moderate and two of severe intensity. There was no non-ocular adverse event with certain relationship to the device. One subject lost light perception (without light localization) in her study eye. CONCLUSIONS: In conclusion, this prospective study, "Safety and Efficacy of Subretinal Implants for Partial Restoration of Vision in Blind Patients," shows that the Retina Implant Alpha IMS is an option for restoring vision using a subretinal stimulation device with a clinically acceptable safety profile.
Authors: K Stingl; K U Bartz-Schmidt; D Besch; F Gekeler; U Greppmaier; G Hörtdörfer; A Koitschev; T Peters; H Sachs; B Wilhelm; E Zrenner Journal: Ophthalmologe Date: 2012-02 Impact factor: 1.059
Authors: Joseph F Rizzo; Douglas B Shire; Shawn K Kelly; Phil Troyk; Marcus Gingerich; Bruce McKee; Attila Priplata; Jinghua Chen; William Drohan; Patrick Doyle; Oscar Mendoza; Luke Theogarajan; Stuart Cogan; John L Wyatt Journal: Conf Proc IEEE Eng Med Biol Soc Date: 2011
Authors: Eberhart Zrenner; Karl Ulrich Bartz-Schmidt; Heval Benav; Dorothea Besch; Anna Bruckmann; Veit-Peter Gabel; Florian Gekeler; Udo Greppmaier; Alex Harscher; Steffen Kibbel; Johannes Koch; Akos Kusnyerik; Tobias Peters; Katarina Stingl; Helmut Sachs; Alfred Stett; Peter Szurman; Barbara Wilhelm; Robert Wilke Journal: Proc Biol Sci Date: 2010-11-03 Impact factor: 5.349
Authors: Lyndon da Cruz; Jessy D Dorn; Mark S Humayun; Gislin Dagnelie; James Handa; Pierre-Olivier Barale; José-Alain Sahel; Paulo E Stanga; Farhad Hafezi; Avinoam B Safran; Joel Salzmann; Arturo Santos; David Birch; Rand Spencer; Artur V Cideciyan; Eugene de Juan; Jacque L Duncan; Dean Eliott; Amani Fawzi; Lisa C Olmos de Koo; Allen C Ho; Gary Brown; Julia Haller; Carl Regillo; Lucian V Del Priore; Aries Arditi; Robert J Greenberg Journal: Ophthalmology Date: 2016-07-21 Impact factor: 12.079
Authors: Katarina Stingl; Ruth Schippert; Karl U Bartz-Schmidt; Dorothea Besch; Charles L Cottriall; Thomas L Edwards; Florian Gekeler; Udo Greppmaier; Katja Kiel; Assen Koitschev; Laura Kühlewein; Robert E MacLaren; James D Ramsden; Johann Roider; Albrecht Rothermel; Helmut Sachs; Greta S Schröder; Jan Tode; Nicole Troelenberg; Eberhart Zrenner Journal: Front Neurosci Date: 2017-08-23 Impact factor: 4.677
Authors: Cyril G Eleftheriou; Jasmina Cehajic-Kapetanovic; Franck P Martial; Nina Milosavljevic; Robert A Bedford; Robert J Lucas Journal: Mol Vis Date: 2017-06-16 Impact factor: 2.367