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Research article
Abhishek Naidu
Stony Brook University Renaissance School of Medicine
Corresponding Author
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Background: Post-implantation visual outcomes in patients with the Argus II Retinal Prosthesis is dependent on a multitude of factors including the positioning of the electrode array on the retina. The purpose of this study is to determine whether the average electrode array-retina gap distance correlates with objective visual function outcomes and sensitivity detection thresholds in patients implanted with the Argus II Retinal Prosthesis.
Methods: 5 patients with implantation of the Argus II Retinal Prosthesis were enrolled in this single-institution retrospective study. Patient demographics were collected from medical records. Visual function data (Square Localization [SL] and Direction of Motion [DOM]) and Optical Coherence Tomography (Cirrus HD-OCT) images were extracted retrospectively from the Argus II Retinal Prosthesis Post-Approval study. Visual function tests were performed with the device OFF and ON at each study visit. Electrode array-retina gap distances were measured at each of the array’s 60 electrodes using the Cirrus HD-OCT software in both the nasotemporal and superoinferior planes. Data was obtained at baseline, and post-operative month 1, month 3, month 6, and year 1. Sensitivity detection thresholds were obtained at the initial programming visit and each reprogramming session.
Results: 1 of 53 patients had a significant average improvementperformed significantly better in the SL visual function test and 0 of 5 had a significant average improvement in the DOM visual when the testing with the device was ON compared to OFF (p < 0.05). Electrode array-retina gap distance did not show a significant correlation with changes in SL . Patients that worsened in visual function (r = 0.20; p = > 0.05) or DOM visual function (r = -0.18; p = > 0.05). In addition,testing with the device ON in both SL and DOM testing had a statistically significant decrease in performance. The electrode array-retina gap distance did not show a significant correlation with was found to effect performance in SL testing in a patient-dependent manner. No effect was found between the electrode-array gap distance and DOM testing or sensitivity detection threshold (r = -0.01; p = 0.98)..
Conclusion: Our results demonstrate that the average electrode array-retina gap distance does not correlate with changes in objectivemay affect visual acuity function or sensitivity detection thresholdsoutcomes in SL testing in a cohort ofcertain patients implanted with the Argus II Retinal Prosthesis. Therefore, and the direction and magnitude of this effect is likely patient-dependent. Furthermore, complete apposition between the electrode array and retina may not always be necessary to achieve optimal visual outcomes.
Keywords
Argus II, Argus II Retinal Prosthesis, Direction of Motion, Electrode array-retina gap, distance, Gap distance, Low vision, Optical Coherence Tomography (OCT), Retinitis, Pigmentosa, Square Localization, Visual Function
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View the published article at BMC Ophthalmology.
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Submission checks complete
On 30 Aug, 2020
Editorial decision: Accept
On 27 Aug, 2020
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On 25 Aug, 2020
Editor invited
On 25 Aug, 2020
Version 2
Posted 22 Aug, 2020
No comments provided
Editor assigned
On 20 Aug, 2020
Submission checks complete
On 19 Aug, 2020
Editor invited
On 19 Aug, 2020
No comments provided
Editorial decision: Major revision
On 05 Jul, 2020
Review #4 received
Received 27 Jun, 2020
Reviewer #4 agreed
On 22 Jun, 2020
Reviewer #3 agreed
On 21 Jun, 2020
Review #2 received
Received 16 Jun, 2020
Review #1 received
Received 16 Jun, 2020
Reviewer #2 agreed
On 14 Jun, 2020
Reviewers invited
Invitations sent on 13 Jun, 2020
Reviewer #1 agreed
On 13 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
Editor invited
On 11 Jun, 2020
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Subject Areas
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See the published version of this preprint at BMC Ophthalmology.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Research article
Abhishek Naidu
Stony Brook University Renaissance School of Medicine
Corresponding Author
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at BMC Ophthalmology.
No community comments so far
Submission checks complete
On 30 Aug, 2020
Editorial decision: Accept
On 27 Aug, 2020
Editor assigned
On 25 Aug, 2020
Editor invited
On 25 Aug, 2020
Version 2
Posted 22 Aug, 2020
No comments provided
Editor assigned
On 20 Aug, 2020
Submission checks complete
On 19 Aug, 2020
Editor invited
On 19 Aug, 2020
No comments provided
Editorial decision: Major revision
On 05 Jul, 2020
Review #4 received
Received 27 Jun, 2020
Reviewer #4 agreed
On 22 Jun, 2020
Reviewer #3 agreed
On 21 Jun, 2020
Review #2 received
Received 16 Jun, 2020
Review #1 received
Received 16 Jun, 2020
Reviewer #2 agreed
On 14 Jun, 2020
Reviewers invited
Invitations sent on 13 Jun, 2020
Reviewer #1 agreed
On 13 Jun, 2020
Editor assigned
On 12 Jun, 2020
Submission checks complete
On 11 Jun, 2020
Editor invited
On 11 Jun, 2020
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
Subject Areas
Ophthalmology
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at BMC Ophthalmology.
Background: Post-implantation visual outcomes in patients with the Argus II Retinal Prosthesis is dependent on a multitude of factors including the positioning of the electrode array on the retina. The purpose of this study is to determine whether the average electrode array-retina gap distance correlates with objective visual function outcomes and sensitivity detection thresholds in patients implanted with the Argus II Retinal Prosthesis.
Methods: 5 patients with implantation of the Argus II Retinal Prosthesis were enrolled in this single-institution retrospective study. Patient demographics were collected from medical records. Visual function data (Square Localization [SL] and Direction of Motion [DOM]) and Optical Coherence Tomography (Cirrus HD-OCT) images were extracted retrospectively from the Argus II Retinal Prosthesis Post-Approval study. Visual function tests were performed with the device OFF and ON at each study visit. Electrode array-retina gap distances were measured at each of the array’s 60 electrodes using the Cirrus HD-OCT software in both the nasotemporal and superoinferior planes. Data was obtained at baseline, and post-operative month 1, month 3, month 6, and year 1. Sensitivity detection thresholds were obtained at the initial programming visit and each reprogramming session.
Results: 1 of 53 patients had a significant average improvementperformed significantly better in the SL visual function test and 0 of 5 had a significant average improvement in the DOM visual when the testing with the device was ON compared to OFF (p < 0.05). Electrode array-retina gap distance did not show a significant correlation with changes in SL . Patients that worsened in visual function (r = 0.20; p = > 0.05) or DOM visual function (r = -0.18; p = > 0.05). In addition,testing with the device ON in both SL and DOM testing had a statistically significant decrease in performance. The electrode array-retina gap distance did not show a significant correlation with was found to effect performance in SL testing in a patient-dependent manner. No effect was found between the electrode-array gap distance and DOM testing or sensitivity detection threshold (r = -0.01; p = 0.98)..
Conclusion: Our results demonstrate that the average electrode array-retina gap distance does not correlate with changes in objectivemay affect visual acuity function or sensitivity detection thresholdsoutcomes in SL testing in a cohort ofcertain patients implanted with the Argus II Retinal Prosthesis. Therefore, and the direction and magnitude of this effect is likely patient-dependent. Furthermore, complete apposition between the electrode array and retina may not always be necessary to achieve optimal visual outcomes.
Figure 1
Figure 2
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