Argus II is a medical device which is implanted in the eye and intended to provide electrical stimulation of the retina for individuals with severe to profound retinitis pigmentosa. Commissioning through Evaluation (CTE) is funded by NHS England and enables new treatments with limited evidence to be commissioned in a small number of centres with a planned evaluation.
The main research question that this study seeks to answer is: How does the Argus II epriretinal implant impact on the quality of life of participants with ultra-low vision as a result of retinitis pigmentosa?
Retinitis pigmentosa (RP) is a rare often inherited condition, with patients initially experiencing ring scotoma and night vision problems. In most cases, the disease slowly progresses and leads to the loss of all peripheral vision and central vision as the disease progresses. The Argus II epiretinal prosthesis has been successfully used in patients with end-stage RP and aims to restore perception of light, movement and shapes by surgically implanting an array of electrodes onto the retina.
This study is for a mixed methods, multicentre, controlled (before vs after design), prospective, interventional study on ten participants to evaluate the impact of the Argus II epiretinal prosthesis on participants’ quality of life. The population will be adults with severe to profound outer retinal ultra low vision (ULV) in both eyes as a result of retinitis pigmentosa.
Participants will receive input from rehabilitation specialists, who provide device use training tailored to the needs of each participant.
Integrating process evaluation and implementation science methods into the study's quantitative and qualitative data collection activities will add value by helping to explain how and why, and in what ways, the intervention was effective or not effective. In addition, the fidelity of the intervention, whether adaptations have been made, how participants use the device and factors associated with success will be captured.
Qualitative and quantitative data will be collected from participants, clinical teams, and rehabilitation specialists at baseline and at various times up to 12 months post-procedure. The final aim of this study is to carry out cost impact analysis of the Argus II procedure and associated rehabilitation which will involve collecting basic data on resource use.
Cedar were commissioned by NICE and NHSE to manage the evaluation of the study which included producing the study protocol and obtaining all of the approvals necessary to start the study. Our role also include carrying out interviews with patients, collecting data, and doing an economic evaluation.
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 withdrew the device from sale in the United Kingdom. Therefore, the study is not going ahead at this time.
White, J., Knight, L., da Cruz, L., Stanga, P. E., Patrick, H., Powell, H., ... & 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), e17436.