Dataset Information

Improvements in vision-related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis.

ABSTRACT: The purpose of this analysis is to report the change in quality of life (QoL) after treatment with the Argus II Epiretinal Prosthesis in patients with end-stage retinitis pigmentosa.The Vision and Quality of Life Index (VisQoL) was used to assess changes in QoL dimensions and overall utility score in a prospective 30-patient single-arm clinical study. VisQoL is a multi-attribute instrument consisting of six dimensions (injury, life, roles, assistance, activity and friendship) that may be affected by visual impairment. Within each dimension, patients were divided into two groups based on how much their QoL was affected by their blindness at baseline (moderate/severe or minimal). Outcomes were compared within each dimension sub-group between baseline and the combined follow-up periods using the Friedman test. In addition, data from the six dimensions were combined into a single utility score, with baseline data compared to the combined follow-up periods.Overall, 80 per cent of the patients reported difficulty in one or more dimensions pre-implant. Composite VisQoL utility scores at follow-up showed no statistically significant change from baseline; however, in three of the six VisQoL dimensions (injury, life and roles), patients with baseline deficits showed significant and lasting improvement after implantation with Argus II. In two of the three remaining dimensions (assistance and activity), data trended toward an improvement. In the final VisQoL dimension (friendship), none of the patients reported baseline deficits, suggesting that patients had largely adjusted to this attribute.Patients whose vision negatively affected them with respect to three VisQoL dimensions (that is, getting injured, coping with the demands of their life and fulfilling their life roles) reported significant improvement in QoL after implantation of the Argus II retinal prosthesis. Furthermore, the benefit did not deteriorate at any point during the 36-month follow-up, suggesting a long-term, durable improvement.

SUBMITTER: Duncan JL

PROVIDER: S-EPMC5347867 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Improvements in vision-related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis.

Duncan Jacque L JL Richards Thomas P TP Arditi Aries A da Cruz Lyndon L Dagnelie Gislin G Dorn Jessy D JD Ho Allen C AC Olmos de Koo Lisa C LC Barale Pierre-Olivier PO Stanga Paulo E PE Thumann Gabriele G Wang Yizhong Y Greenberg Robert J RJ

Clinical & experimental optometry 20160825 2

<h4>Background</h4>The purpose of this analysis is to report the change in quality of life (QoL) after treatment with the Argus II Epiretinal Prosthesis in patients with end-stage retinitis pigmentosa.<h4>Methods</h4>The Vision and Quality of Life Index (VisQoL) was used to assess changes in QoL dimensions and overall utility score in a prospective 30-patient single-arm clinical study. VisQoL is a multi-attribute instrument consisting of six dimensions (injury, life, roles, assistance, activity ...[more]

PMID: 27558213

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Project description:BackgroundRetinitis 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.ObjectiveThe aim of this study was to assess the effect of the Argus II device on patient's daily activities and quality of life.MethodsThis 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.ResultsThis 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.ConclusionsThe 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.

Dataset Information

Improvements in vision-related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis.

Publications

Improvements in vision-related quality of life in blind patients implanted with the Argus II Epiretinal Prosthesis.

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