Argus II commissioning through evaluation study (ACE)
Research type
Research Study
Full title
A prospective, single arm, mixed methods interventional study to assess the impact of the Argus II epiretinal prosthesis on the quality of life of patients with ultra-low vision due to retinitis pigmentosa
IRAS ID
241612
Contact name
Timothy L. Jackson
Contact email
Sponsor organisation
King's College London
Clinicaltrials.gov Identifier
241612, IRAS number; NIHR128190, NIHR award number
Duration of Study in the UK
2 years, 5 months, 30 days
Research summary
We want to find out how having the Argus II device affects the lives of people with very low vision due to retinitis pigmentosa (RP). RP is a disease which causes people to lose their vision over time. Vision loss affects people’s ability to carry out daily tasks and can also reduce their quality of life.
The Argus II device is implanted inside a person’s eye during a surgical procedure. The person wears a pair of glasses which have a small video camera attached. This camera records the scene in front of the person. The digital image is converted to electrical impulses and sent to a device inside the person’s eye. People with the device can see areas of light and dark but it does not restore their normal vision.
Previous research has shown that the Argus II device may improve people’s vision. We want to find out whether this translates into people having an improved quality of life.
To answer this question, 10 participants with severe vision loss due to retinitis pigmentosa will have the Argus II device surgically implanted in an NHS hospital. Data about the procedure and complications will be collected. Participants will receive training and rehabilitation to help them use the device at home.
Participants will be asked to take part in in-depth interviews with independent researchers before their operation and after 1 year. Participants will also be asked to complete questionnaires about their vision, quality of life, whether they’ve felt symptoms of anxiety or depression, and their experiences with the Argus II implant at several time points during the study. These approaches will allow researchers to hear participants’ opinions about the device directly.
Two patients who have had the Argus II implant in the past have helped us design this study.
REC name
London - Camberwell St Giles Research Ethics Committee
REC reference
19/LO/0429
Date of REC Opinion
25 Apr 2019
REC opinion
Further Information Favourable Opinion