Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study

Judith White; Laura Knight; Lyndon da Cruz; Paulo E. Stanga; Hannah Patrick; Helen Powell; Lee Berry; Kathleen Withers; Grace Carolan-Rees; Timothy L. Jackson

doi:10.2196/17436

Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study

Judith White^*, Laura Knight, Lyndon da Cruz, Paulo E. Stanga, Hannah Patrick, Helen Powell, Lee Berry, Kathleen Withers, Grace Carolan-Rees, Timothy L. Jackson

^*Corresponding author for this work

Ophthalmology

Research output: Contribution to journal › Article › peer-review

5 Citations (Scopus)

Abstract

Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work.

Original language	English
Article number	e17436
Journal	JMIR research protocols
Volume	10
Issue number	1
DOIs	https://doi.org/10.2196/17436
Publication status	Published - Jan 2021

Keywords

Artificial vision
Functional vision
Low vision
Patient-reported outcomes
Qualitative methods
Quality of life
Ultra-low vision
Visual function
Visual function questionnaire

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10.2196/17436

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White, J., Knight, L., da Cruz, L., Stanga, P. E., Patrick, H., Powell, H., Berry, L., Withers, K., Carolan-Rees, G., & Jackson, T. L. (2021). Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study. JMIR research protocols, 10(1), Article e17436. https://doi.org/10.2196/17436

@article{5f0bfb843a034ebdac8adb5817759c0a,

title = "Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study",

abstract = "Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients{\textquoteright} quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England{\textquoteright}s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient{\textquoteright}s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users{\textquoteright} experiences with the procedure, the device, and rehabilitation. The effect of the device on patients{\textquoteright} functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants{\textquoteright} quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work.",

keywords = "Artificial vision, Functional vision, Low vision, Patient-reported outcomes, Qualitative methods, Quality of life, Ultra-low vision, Visual function, Visual function questionnaire",

author = "Judith White and Laura Knight and {da Cruz}, Lyndon and Stanga, {Paulo E.} and Hannah Patrick and Helen Powell and Lee Berry and Kathleen Withers and Grace Carolan-Rees and Jackson, {Timothy L.}",

note = "Funding Information: This study is funded through NHS England{\textquoteright}s Commissioning through Evaluation program and a grant from the National Institute for Health Research (grant reference: NIHR 128190). Cedar has also been funded by NICE to undertake nonresearch activities. NICE and NHS England have been involved in the design of the study. None of the funding bodies will be involved in the collection, analysis, or interpretation of the study results. The authors sincerely thank the patient representatives for their time and contribution to the design of this study. We thank Andy Fisher (Focal Point UK) for his contributions to the rehabilitation program delivery and evaluation planning. Contributors from NHS England are also acknowledged. Funding Information: Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients{\textquoteright} quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England{\textquoteright}s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient{\textquoteright}s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users{\textquoteright} experiences with the procedure, the device, and rehabilitation. The effect of the device on patients{\textquoteright} functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants{\textquoteright} quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/17436 Funding Information: This study is funded through NHS England?s Commissioning through Evaluation program and a grant from the National Institute for Health Research (grant reference: NIHR 128190). Cedar has also been funded by NICE to undertake nonresearch activities. NICE and NHS England have been involved in the design of the study. None of the funding bodies will be involved in the collection, analysis, or interpretation of the study results. The authors sincerely thank the patient representatives for their time and contribution to the design of this study. We thank Andy Fisher (Focal Point UK) for his contributions to the rehabilitation program delivery and evaluation planning. Contributors from NHS England are also acknowledged. Publisher Copyright: {\textcopyright} Judith White, Laura Knight, Lyndon da Cruz, Paulo E Stanga, Hannah Patrick, Helen Powell, Lee Berry, Kathleen Withers, Grace Carolan-Rees, Timothy L Jackson. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.",

year = "2021",

month = jan,

doi = "10.2196/17436",

language = "English",

volume = "10",

journal = "JMIR research protocols",

issn = "1929-0748",

publisher = "JMIR Publications Inc.",

number = "1",

}

White, J, Knight, L, da Cruz, L, Stanga, PE, Patrick, H, Powell, H, Berry, L, Withers, K, Carolan-Rees, G & Jackson, TL 2021, 'Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study', JMIR research protocols, vol. 10, no. 1, e17436. https://doi.org/10.2196/17436

TY - JOUR

T1 - Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa

T2 - Protocol for a single-arm, mixed methods study

AU - White, Judith

AU - Knight, Laura

AU - da Cruz, Lyndon

AU - Stanga, Paulo E.

AU - Patrick, Hannah

AU - Powell, Helen

AU - Berry, Lee

AU - Withers, Kathleen

AU - Carolan-Rees, Grace

AU - Jackson, Timothy L.

N1 - Funding Information: This study is funded through NHS England’s Commissioning through Evaluation program and a grant from the National Institute for Health Research (grant reference: NIHR 128190). Cedar has also been funded by NICE to undertake nonresearch activities. NICE and NHS England have been involved in the design of the study. None of the funding bodies will be involved in the collection, analysis, or interpretation of the study results. The authors sincerely thank the patient representatives for their time and contribution to the design of this study. We thank Andy Fisher (Focal Point UK) for his contributions to the rehabilitation program delivery and evaluation planning. Contributors from NHS England are also acknowledged. Funding Information: Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work. International Registered Report Identifier (IRRID): PRR1-10.2196/17436 Funding Information: This study is funded through NHS England?s Commissioning through Evaluation program and a grant from the National Institute for Health Research (grant reference: NIHR 128190). Cedar has also been funded by NICE to undertake nonresearch activities. NICE and NHS England have been involved in the design of the study. None of the funding bodies will be involved in the collection, analysis, or interpretation of the study results. The authors sincerely thank the patient representatives for their time and contribution to the design of this study. We thank Andy Fisher (Focal Point UK) for his contributions to the rehabilitation program delivery and evaluation planning. Contributors from NHS England are also acknowledged. Publisher Copyright: © Judith White, Laura Knight, Lyndon da Cruz, Paulo E Stanga, Hannah Patrick, Helen Powell, Lee Berry, Kathleen Withers, Grace Carolan-Rees, Timothy L Jackson. Copyright: Copyright 2021 Elsevier B.V., All rights reserved.

PY - 2021/1

Y1 - 2021/1

N2 - Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work.

AB - Background: Retinitis pigmentosa is an incurable, degenerative retinal condition causing progressive sight loss, significantly affecting patients’ quality of life. The Argus II Retinal Prosthesis is a surgically implanted medical device that delivers electrical stimulation to the retina. It is intended to produce a form of artificial vision for blind people with severe-to-profound retinitis pigmentosa by stimulating the remaining viable retinal cells to induce visual perception. This study has been initiated by National Health Service England’s Commissioning through Evaluation program and funded through the National Institute of Health Research of the United Kingdom. Objective: The aim of this study was to assess the effect of the Argus II device on patient’s daily activities and quality of life. Methods: This protocol is a prospective, single-arm, open-label, mixed methods study on 10 consecutive participants receiving the Argus II device. The patient representatives played an integral role in the design of this study. Eligibility criteria include ultra-low vision in both eyes as a result of end-stage retinitis pigmentosa and a willingness and capacity to complete the postimplantation rehabilitation program. Participants will be interviewed by independent researchers at baseline and 12 months later by using a semistructured, in-depth approach, alongside validated questionnaires (Impact of Vision Impairment-Very Low Vision, 5-level EuroQoL-5 dimensions scale, EuroQoL-visual analog scale, and Hospital Anxiety and Depression Scale) and a bespoke device-related questionnaire, which includes questions about users’ experiences with the procedure, the device, and rehabilitation. The effect of the device on patients’ functional vision and activities of daily living will be assessed by vision rehabilitation specialists using a set of tests measured on an ordinal scale (eg, ability to locate objects and avoid obstacles). Clinical outcomes include full-field stimulus light threshold, square localization, direction of motion, grating visual acuity, Landolt-C, procedural success, and adverse events. Qualitative and quantitative outcomes will be linked in a single database to enable individual participant measures to be considered in toto, comparing baseline to the final review. Results: This study was approved by the local ethics committee on April 24, 2019 (London-Camberwell St. Giles Research Ethics Committee, reference 19/LO/0429). It has also been approved by the Health Research Authority and Health and Care Research Wales. At the time of protocol writing, Argus II was available for use in the United Kingdom; however, the manufacturer recently withdrew the Argus II device from sale in the United Kingdom. Therefore, the study is not going ahead at this time. Conclusions: The mixed methods approach provides a rich and in-depth assessment of the effect of the device on participants’ quality of life. Despite the work not going ahead, the publication of this publicly funded protocol is important for researchers planning similar work.

KW - Artificial vision

KW - Functional vision

KW - Low vision

KW - Patient-reported outcomes

KW - Qualitative methods

KW - Quality of life

KW - Ultra-low vision

KW - Visual function

KW - Visual function questionnaire

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AN - SCOPUS:85100501054

SN - 1929-0748

VL - 10

JO - JMIR research protocols

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M1 - e17436

ER -

Effects of the argus II retinal prosthesis system on the quality of life of patients with ultra-low vision due to retinitis pigmentosa: Protocol for a single-arm, mixed methods study

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