title: Safety evaluation of "retina implant alpha IMS"--a prospective clinical trial.
abstract: 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.affiliation: Centre for Ophthalmology, University of Tübingen, Schleichstr. 12, 72076, Tübingen, Germany.
authors.forename: Veronique B D
authors.initials: VB
authors.lastname: Kitiratschky
authors.forename: Katarina
authors.initials: K
authors.lastname: Stingl
authors.forename: Barbara
authors.initials: B
authors.lastname: Wilhelm
authors.forename: Tobias
authors.initials: T
authors.lastname: Peters
authors.forename: Dorothea
authors.initials: D
authors.lastname: Besch
authors.forename: Helmut
authors.initials: H
authors.lastname: Sachs
authors.forename: Florian
authors.initials: F
authors.lastname: Gekeler
authors.forename: Karl Ulrich
authors.initials: KU
authors.lastname: Bartz-Schmidt
authors.forename: Eberhart
authors.initials: E
authors.lastname: Zrenner
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D004599:Electric Stimulation Therapy / Q000295:instrumentation; D004567:Electrodes, Implanted / Q000009:adverse effects*; D005451:Fluorescein Angiography; D006801:Humans; D007429:Intraocular Pressure; D057130:Leber Congenital Amaurosis / Q000601:surgery*; D008875:Middle Aged; D011446:Prospective Studies; D012160:Retina / Q000601:surgery*; D012174:Retinitis Pigmentosa / Q000601:surgery*; D016037:Single-Blind Method; D041623:Tomography, Optical Coherence; D014786:Vision Disorders / Q000534:rehabilitation*; D057488:Visual Prosthesis / Q000009:adverse effects*