IRIS PILOT - Extended Pilot Study With a Retinal Implant System

Retinitis Pigmentosa Clinical Trial

Official title:

Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00427180
• Other study ID #: SP-80-00-00-00-01-V01
• Secondary ID: SP-80-00-00-00-0
• Status: Active, not recruiting
• Phase: N/A
• First received: January 25, 2007
• Last updated: March 2, 2010
• Start date: December 2006
• Est. completion date: December 2010

Study information

• Verified date: March 2010
• Source: Intelligent Medical Implants GmbH
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical DevicesUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Switzerland: SwissmedicAustria: Federal Office for Safety in Health Care
• Study type: Interventional

Clinical Trial Summary

Investigate whether blind subjects that fulfil the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.

Description:

The Retinal Implant System consists of three main components, the Retinal Stimulator, which is the component actually implanted into the eye, the visual interface, and the Pocket Processor The Retinal Stimulator will be implanted into the eye of a blind subject during a surgical operation. However, the external components are activated only during the test sessions under the control of the investigator team. In a first step of the investigation a software controlled system on a PC which is connected to the Pocket Processor via Ethernet interface, will generate the defined stimulation patterns (bars, crosses, cubes). During the test session, the blind subject is exposed to a series of these stimulation patterns and he / she has to describe the visual perceptions. Based on his descriptions and in an interactive way, the stimulation signal is subsequently be modulated by changing parameters like amplitude, duration of impulse, polarity, number of repetitions or pulse frequency on the PC.

In a second step the visual interface is equipped with a camera which presents realtime images to the subject. Data obtained from the investigation with computer generated patterns in the first step are used in the second step to improve the fitting software for the use in the camera supported system.

Finally the system should enable the subject to recognize simple images supported from the camera.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 79 Years

Eligibility

Inclusion Criteria

• Age between 30 and 79 years at the date of enrollment

• Normal hearing and linguistic understanding (with hearing aids if - necessary and in the language of the hospital or in English)

• Ability to understand the study and procedures involved

• Willingness to participate and comply with follow-up procedures

• Good general health based on investigator's opinion

• Ability to undergo surgery using general anaesthesia

• Signed informed consent

• RP, choroideremia, or rod cone dystrophy

• Visual field less than 40 ° (if measurable)

• Visual acuity not better than (1/50), (logMAR=1.7)

• Visual function stable for a duration of at least one year (according to subject statement)

• Normal eye pressure (9-21 mmHg)

• Bulbus length (AP) between 21 and 25 mm

Exclusion Criteria

• Allergic response to multiple antibiotics

• Known allergies to materials of the implant

• Known carrier of multi-resistant organisms

• Pregnancy or lactating

• History of epileptic seizures

• Having active implantable devices (or need within the next 3 years)

• Patients with cancer or patients received cancer therapy within the last 2 years

• Currently undergoing psychiatric treatment without expert opinion approving participation on the study

• Patients having insufficient mental capacity

• Neurological diseases, in particular those affecting nerve conduction velocities

• Patients currently taking medications affecting brain function

• Immunosuppressive subjects

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Choroideremia
• Cone-Rod Dystrophy
• Retinitis
• Retinitis Pigmentosa

Intervention

Device:
• Retinal Implant System (IRIS)
AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Intelligent Medical Implants GmbH

References & Publications (1)

Hornig R, Laube T, Walter P, Velikay-Parel M, Bornfeld N, Feucht M, Akguel H, Rössler G, Alteheld N, Lütke Notarp D, Wyatt J, Richard G. A method and technical equipment for an acute human trial to evaluate retinal implant technology. J Neural Eng. 2005 Mar;2(1):S129-34. Epub 2005 Feb 22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Investigate whether blind subjects that fulfill the patient criteria provided with a Retinal Implant are able to differentiate between simple patterns like horizontal bar, vertical bar and cross.		18 months	No
Secondary	Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters		18 months	Yes