Clinical Trials
Acute study
Successful clinical study with the retinal imlant of IMI
In October 2003, IMI Intelligent Medical Implants started an acute trial in four European centres, in which only patients with Retinitis pigmentosa took part.
The study investigated the ability of the retina to be stimulated electrically.
The test itself lasted for 45 minutes after which the foil, which was connected externally via a cable, was removed and the surgical incision closed. The study was successfully completed with 19 out of 20 totally blind people reporting a visual perception which had been triggered by electrical stimulation.
First chronic study
In the fourth quarter of 2005, IMI Intelligent Medical Implants started a clinical chronic pilot study at the medical university, Hamburg with Dr. Gisbert Richard, Prof. of Ophthalmology. Four patients were operated and received an implant. Simple patterns could be recognised and the location of the stimulation impulses could be identified.
The goal of the trial was to produce visual perceptions and to ascertain the different impressions of their brightness, shape, colour and duration.
Second chronic study
A second chronic study was initiated in 2007. The learning success and the improvement in visual perception have been recorded at regular intervals with the aid of various eyesight tests. A training program was implemented in which the study participants could learn to use their visual perception optimally. Simulation tests were performed to adapt the settings of the Intelligent Retina Implant System individually to each patient.
Criteria of the past study:
- RP, rod cone dystrophy or choroideremia
- Age: 30 years or older
- No perception of form in both eyes (visual acuity 1% or worse)
- Ability to undergo surgery under general anaesthesia
- Sufficient hearing and speech comprehension (including with a hearing aid)
Our clinical partner in the clinical study in UK
Moorfields Eye Hospital
162 City Road
London EC1V 2PD, UK
Verantwortlicher Prüfarzt: Mr. G.W. Aylward
Tel.: +44 (0)20 7253 3411
Fax: +44 (0)20 7253 4696
Email: bill.aylward@moorfields.nhs.uk