Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study

Ninel Z Gregori; Natalia F Callaway; Catherine Hoeppner; Alex Yuan; Aleksandra Rachitskaya; William Feuer; Hossein Ameri; J Fernando Arevalo; Albert J Augustin; David G Birch; Gislin Dagnelie; Salvatore Grisanti; Janet L Davis; Paul Hahn; James T Handa; Allen C Ho; Suber S Huang; Mark S Humayun; Raymond Iezzi; K Thiran Jayasundera; Gregg T Kokame; Byron L Lam; Jennifer I Lim; Naresh Mandava; Sandra R Montezuma; Lisa Olmos de Koo; Peter Szurman; Lejla Vajzovic; Peter Wiedemann; James Weiland; Jiong Yan; David N Zacks

doi:10.1016/j.ajo.2018.06.012

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study

Ninel Z Gregori, Natalia F Callaway, Catherine Hoeppner, Alex Yuan, Aleksandra Rachitskaya, William Feuer, Hossein Ameri, J Fernando Arevalo, Albert J Augustin, David G Birch, Gislin Dagnelie, Salvatore Grisanti, Janet L Davis, Paul Hahn, James T Handa, Allen C Ho, Suber S Huang, Mark S Humayun, Raymond Iezzi, K Thiran JayasunderaGregg T Kokame, Byron L Lam, Jennifer I Lim, Naresh Mandava, Sandra R Montezuma, Lisa Olmos de Koo, Peter Szurman, Lejla Vajzovic, Peter Wiedemann, James Weiland, Jiong Yan, David N Zacks

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.

Original language	English
Journal	American Journal of Ophthalmology
Volume	193
Pages (from-to)	87-99
Number of pages	13
ISSN	0002-9394
DOIs	https://doi.org/10.1016/j.ajo.2018.06.012
Publication status	Published - 09.2018

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Gregori, N. Z., Callaway, N. F., Hoeppner, C., Yuan, A., Rachitskaya, A., Feuer, W., Ameri, H., Arevalo, J. F., Augustin, A. J., Birch, D. G., Dagnelie, G., Grisanti, S., Davis, J. L., Hahn, P., Handa, J. T., Ho, A. C., Huang, S. S., Humayun, M. S., Iezzi, R., ... 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, 87-99. https://doi.org/10.1016/j.ajo.2018.06.012

@article{558e8127e997413c88ea4f8ade9dbd9c,

title = "Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study",

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.",

author = "Gregori, {Ninel Z} and Callaway, {Natalia F} and Catherine Hoeppner and Alex Yuan and Aleksandra Rachitskaya and William Feuer and Hossein Ameri and Arevalo, {J Fernando} and Augustin, {Albert J} and Birch, {David G} and Gislin Dagnelie and Salvatore Grisanti and Davis, {Janet L} and Paul Hahn and Handa, {James T} and Ho, {Allen C} and Huang, {Suber S} and Humayun, {Mark S} and Raymond Iezzi and Jayasundera, {K Thiran} and Kokame, {Gregg T} and Lam, {Byron L} and Lim, {Jennifer I} and Naresh Mandava and Montezuma, {Sandra R} and {Olmos de Koo}, Lisa and Peter Szurman and Lejla Vajzovic and Peter Wiedemann and James Weiland and Jiong Yan and Zacks, {David N}",

year = "2018",

month = sep,

doi = "10.1016/j.ajo.2018.06.012",

language = "English",

volume = "193",

pages = "87--99",

journal = "American Journal of Ophthalmology",

issn = "0002-9394",

}

Gregori, NZ, Callaway, NF, Hoeppner, C, Yuan, A, Rachitskaya, A, Feuer, W, Ameri, H, Arevalo, JF, Augustin, AJ, Birch, DG, Dagnelie, G, Grisanti, S, Davis, JL, Hahn, P, Handa, JT, Ho, AC, Huang, SS, Humayun, MS, Iezzi, R, Jayasundera, KT, Kokame, GT, Lam, BL, Lim, JI, Mandava, N, Montezuma, SR, Olmos de Koo, L, Szurman, P, Vajzovic, L, Wiedemann, P, Weiland, J, Yan, J & Zacks, DN 2018, 'Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study', American Journal of Ophthalmology, vol. 193, pp. 87-99. https://doi.org/10.1016/j.ajo.2018.06.012

TY - JOUR

T1 - Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation

T2 - 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

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

PY - 2018/9

Y1 - 2018/9

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.

AB - 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.

U2 - 10.1016/j.ajo.2018.06.012

DO - 10.1016/j.ajo.2018.06.012

M3 - Journal articles

C2 - 29940167

SN - 0002-9394

VL - 193

SP - 87

EP - 99

JO - American Journal of Ophthalmology

JF - American Journal of Ophthalmology

ER -

Retinal Anatomy and Electrode Array Position in Retinitis Pigmentosa Patients After Argus II Implantation: An International Study

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