Artificial Vision Clinical Trials
Epiretinal Devices
An epiretinal prosthetic device ('Second Sight Retinal Prosthesis') is currently being tested in human subjects. A 16 electrode device ("Argus I") has already been successfully implanted in 6 patients and safety and efficacy tested. All patients responded with restoration of light perception. Some had significant restoration of vision including shape recognition.
A relatively large on-going fully recruited international multi-centre trial (including Moorfields Eye Hospital, UK) of a 60 electrode implant ('Second Sight Retinal Prosthesis') began in 2008. It involves a wearable camera and a retinal prosthesis collectively called the "Argus II" system. End stage RP patients were eligible for participation. Confirmation of a history of RP and remaining visual acuity of bare light perception or worse in both eyes was mandatory. Approximately 30 patients have had implants. Preliminary reports are promising and further data is keenly awaited (January 2011).
Further information is available at:
clinicaltrials.gov/ct/show/NCT00407602?order=1
medgadget.com/archives/2007/01/second_sight_me.html
Subretinal Devices
A group in Germany led by Professor Zrenner has been doing research on a subretinal implant (placed between the RPE and overlying retinal layers Figure 2 About RP Section) for a number of years. A preliminary study has been completed (2008). The implant contains 1500 microelectrodes. It is 3x3 mm in size and 70 microns thick producing a field of 12 degrees, enough for mobility and recognition of objects. The implant is being developed by Retina Implant AG.
An epiretinal prosthetic device ('Second Sight Retinal Prosthesis') is currently being tested in human subjects. A 16 electrode device ("Argus I") has already been successfully implanted in 6 patients and safety and efficacy tested. All patients responded with restoration of light perception. Some had significant restoration of vision including shape recognition.
A relatively large on-going fully recruited international multi-centre trial (including Moorfields Eye Hospital, UK) of a 60 electrode implant ('Second Sight Retinal Prosthesis') began in 2008. It involves a wearable camera and a retinal prosthesis collectively called the "Argus II" system. End stage RP patients were eligible for participation. Confirmation of a history of RP and remaining visual acuity of bare light perception or worse in both eyes was mandatory. Approximately 30 patients have had implants. Preliminary reports are promising and further data is keenly awaited (January 2011).
Further information is available at:
clinicaltrials.gov/ct/show/NCT00407602?order=1
medgadget.com/archives/2007/01/second_sight_me.html
Subretinal Devices
A group in Germany led by Professor Zrenner has been doing research on a subretinal implant (placed between the RPE and overlying retinal layers Figure 2 About RP Section) for a number of years. A preliminary study has been completed (2008). The implant contains 1500 microelectrodes. It is 3x3 mm in size and 70 microns thick producing a field of 12 degrees, enough for mobility and recognition of objects. The implant is being developed by Retina Implant AG.
The preliminary study of 7 people with RP was designed to last 4 weeks although in one patient the retinal device remains implanted after 18 months. Six of the seven people with RP have had light perception restored. Two patients could discern simple patterns. Three patients could locate a bright object such as a light coloured plate. One of the advantages of this device is that there is no external camera or power source – everything is located within the eye. A larger multi-centre study (including King's College Hospital and the John Radcliffe Hospital in the UK) is currently recruiting (2011).
Further information is available at:
clinicaltrials.gov/ct2/show/NCT01024803?term=retina+implant+ag&rank=2
Further information is available at:
clinicaltrials.gov/ct2/show/NCT01024803?term=retina+implant+ag&rank=2
