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Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study.
Am J Ophthalmol 2018; 193:87-99AJ

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.

Authors+Show Affiliations

Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA. Electronic address: ngregori@med.miami.edu.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.USC Roski Eye Institute, University of Southern California, Los Angeles, California, USA.The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.Städtisches Klinikum, Augenklinik, Karlsruhe, Germany.Retina Foundation of the Southwest, Dallas, Texas, USA.Lions Vision Research and Rehabilitation Center, The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.University Eye Clinic Luebeck at the University Hospital Schleswig-Holstein, Lübeck, Germany.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.Duke University Eye Center, Durham, North Carolina, USA.The Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.Wills Eye Hospital, Thomas Jefferson University, Philadelphia, Pennsylvania, USA.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA; Retina Center of Ohio, Cleveland, Ohio, USA.USC Roski Eye Institute, University of Southern California, Los Angeles, California, USA; USC Ginsburg Institute for Biomedical Therapeutics, Los Angeles, California, USA.Mayo Clinic, Rochester, Minnesota, USA.Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.Retina Consultants of Hawaii, Aiea, Hawaii, USA.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida, USA.University of Illinois at Chicago, Chicago, Illinois, USA.University of Colorado, Aurora, Colorado, USA.University of Minnesota, Minneapolis, Minnesota, USA.USC Roski Eye Institute, University of Southern California, Los Angeles, California, USA.Eye Clinic Sulzbach, Knappschaft Hospital Saar, Sulzbach, Germany.Duke University Eye Center, Durham, North Carolina, USA.Klinik und Poliklinik für Augenheilkunde, Universitätsklinikum Leipzig, Leipzig, Germany.Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.Emory Eye Center, Emory University, Atlanta, Georgia, USA.Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA.

Pub Type(s)

Journal Article
Multicenter Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't
Research Support, U.S. Gov't, Non-P.H.S.

Language

eng

PubMed ID

29940167

Citation

Gregori, Ninel Z., et al. "Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: an International Study." American Journal of Ophthalmology, vol. 193, 2018, pp. 87-99.
Gregori NZ, Callaway NF, Hoeppner C, et al. Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study. Am J Ophthalmol. 2018;193:87-99.
Gregori, N. Z., Callaway, N. F., Hoeppner, C., Yuan, A., Rachitskaya, A., Feuer, W., ... Zacks, D. N. (2018). Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study. American Journal of Ophthalmology, 193, pp. 87-99. doi:10.1016/j.ajo.2018.06.012.
Gregori NZ, et al. Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: an International Study. Am J Ophthalmol. 2018;193:87-99. PubMed PMID: 29940167.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study. AU - Gregori,Ninel Z, AU - Callaway,Natalia F, AU - Hoeppner,Catherine, AU - Yuan,Alex, AU - Rachitskaya,Aleksandra, AU - Feuer,William, AU - Ameri,Hossein, AU - Arevalo,J Fernando, AU - Augustin,Albert J, AU - Birch,David G, AU - Dagnelie,Gislin, AU - Grisanti,Salvatore, AU - Davis,Janet L, AU - Hahn,Paul, AU - Handa,James T, AU - Ho,Allen C, AU - Huang,Suber S, AU - Humayun,Mark S, AU - Iezzi,Raymond,Jr AU - Jayasundera,K Thiran, AU - Kokame,Gregg T, AU - Lam,Byron L, AU - Lim,Jennifer I, AU - Mandava,Naresh, AU - Montezuma,Sandra R, AU - Olmos de Koo,Lisa, AU - Szurman,Peter, AU - Vajzovic,Lejla, AU - Wiedemann,Peter, AU - Weiland,James, AU - Yan,Jiong, AU - Zacks,David N, Y1 - 2018/06/27/ PY - 2018/03/10/received PY - 2018/06/12/revised PY - 2018/06/13/accepted PY - 2018/6/26/pubmed PY - 2019/8/14/medline PY - 2018/6/26/entrez SP - 87 EP - 99 JF - American journal of ophthalmology JO - Am. J. Ophthalmol. VL - 193 N2 - 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. SN - 1879-1891 UR - https://www.unboundmedicine.com/medline/citation/29940167/Retinal_Anatomy_and_Electrode_Array_Position_in_Retinitis_Pigmentosa_Patients_After_Argus_II_Implantation:_An_International_Study_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0002-9394(18)30291-5 DB - PRIME DP - Unbound Medicine ER -