Ninel Z Gregori1, Natalia F Callaway2, Catherine Hoeppner2, Alex Yuan3, Aleksandra Rachitskaya3, William Feuer2, Hossein Ameri4, J Fernando Arevalo5, Albert J Augustin6, David G Birch7, Gislin Dagnelie8, Salvatore Grisanti9, Janet L Davis2, Paul Hahn10, James T Handa5, Allen C Ho11, Suber S Huang12, Mark S Humayun13, Raymond Iezzi14, K Thiran Jayasundera15, Gregg T Kokame16, Byron L Lam2, Jennifer I Lim17, Naresh Mandava18, Sandra R Montezuma19, Lisa Olmos de Koo4, Peter Szurman20, Lejla Vajzovic10, Peter Wiedemann21, James Weiland15, Jiong Yan22, David N Zacks15. 1. Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. Electronic address: ngregori@med.miami.edu. 2. Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. 3. Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. 4. USC Roski Eye Institute, University of Southern California, Los Angeles, California, USA. 5. The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 6. Städtisches Klinikum, Augenklinik, Karlsruhe, Germany. 7. Retina Foundation of the Southwest, Dallas, Texas, USA. 8. Lions Vision Research and Rehabilitation Center, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA. 9. University Eye Clinic Luebeck at the University Hospital Schleswig-Holstein, Lübeck, Germany. 10. Duke University Eye Center, Durham, North Carolina, USA. 11. Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania, USA. 12. Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA; Retina Center of Ohio, Cleveland, Ohio, USA. 13. USC Roski Eye Institute, University of Southern California, Los Angeles, California, USA; USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, California, USA. 14. Mayo Clinic, Rochester, Minnesota, USA. 15. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. 16. Retina Consultants of Hawaii, Aiea, Hawaii, USA. 17. University of Illinois at Chicago, Chicago, Illinois, USA. 18. University of Colorado, Aurora, Colorado, USA. 19. University of Minnesota, Minneapolis, Minnesota, USA. 20. Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany. 21. Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Leipzig, Leipzig, Germany. 22. Emory Eye Center, Emory University, Atlanta, Georgia, USA.
Abstract
PURPOSE: To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients. DESIGN: Prospective, noncomparative cohort study. METHODS: Setting: International multicenter study. PATIENTS: Argus II recipients enrolled in the Post-Market Surveillance Studies. PROCEDURES: Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc-array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months. MAIN OUTCOME MEASURES: Axial retinal thickness and axial gap along the array's long axis (a line between the tack and handle); maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle. RESULTS: Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (P = .007). The rate of maximal thickness increase was highest near the array midline (slope = 6.02, P = .004), compared to the tack (slope = 3.60, P < .001) or the handle (slope = 1.93, P = .368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (P = .032). Optic disc-array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation. CONCLUSIONS: Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.
PURPOSE: To assess the retinal anatomy and array position in Argus II retinal prosthesis recipients. DESIGN: Prospective, noncomparative cohort study. METHODS: Setting: International multicenter study. PATIENTS: Argus II recipients enrolled in the Post-Market Surveillance Studies. PROCEDURES: Spectral-domain optical coherence tomography images collected for the Surveillance Studies (NCT01860092 and NCT01490827) were reviewed. Baseline and postoperative macular thickness, electrode-retina distance (gap), optic disc-array overlap, and preretinal membrane presence were recorded at 1, 3, 6, and 12 months. MAIN OUTCOME MEASURES: Axial retinal thickness and axial gap along the array's long axis (a line between the tack and handle); maximal retinal thickness and maximal gap along a B-scan near the tack, midline, and handle. RESULTS: Thirty-three patients from 16 surgical sites in the United States and Germany were included. Mean axial retinal thickness increased from month 1 through month 12 at each location, but reached statistical significance only at the array midline (P = .007). The rate of maximal thickness increase was highest near the array midline (slope = 6.02, P = .004), compared to the tack (slope = 3.60, P < .001) or the handle (slope = 1.93, P = .368). The mean axial and maximal gaps decreased over the study period, and the mean maximal gap size decrease was significant at midline (P = .032). Optic disc-array overlap was seen in the minority of patients. Preretinal membranes were common before and after implantation. CONCLUSIONS: Progressive macular thickening under the array was common and corresponded to decreased electrode-retina gap over time. By month 12, the array was completely apposed to the macula in approximately half of the eyes.
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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