IRIS PILOT - Extended Pilot Study With a Retinal Implant System

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Intelligent Medical Implants GmbH.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Intelligent Medical Implants GmbH
ClinicalTrials.gov Identifier:
NCT00427180
First received: January 25, 2007
Last updated: March 2, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Retinitis Pigmentosa
Cone-Rod Dystrophy
Choroideremia
Device: Retinal Implant System (IRIS)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System

Resource links provided by NLM:


Further study details as provided by Intelligent Medical Implants GmbH:

Primary Outcome Measures:
  • 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. [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Secondary goals of this study phase are: Further evaluation of stimulation parameters, Light localization with use of camera, Safety verification of stimulation parameters [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: December 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Retinal Implant System (IRIS)
    AIMD - Active Implantable Medical Device designed for artificial electrical neural stimulation of photoreceptor degenerated retina
    Other Name: IRIS
Detailed 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.

  Eligibility

Ages Eligible for Study:   30 Years to 79 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427180

Sponsors and Collaborators
Intelligent Medical Implants GmbH
Investigators
Principal Investigator: Gisbert Richard, Prof. Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf
  More Information

Additional Information:
Publications:
Responsible Party: Intelligent Medical Implants GmbH, Medical device industry
ClinicalTrials.gov Identifier: NCT00427180     History of Changes
Other Study ID Numbers: SP-80-00-00-00-01-V01, SP-80-00-00-00-02-V01, SP-80-00-00-00-03-V01
Study First Received: January 25, 2007
Last Updated: March 2, 2010
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Switzerland: Swissmedic
Austria: Federal Office for Safety in Health Care

Keywords provided by Intelligent Medical Implants GmbH:
Visual Perception
Retina
Light
Retinitis Pigmentosa
Visual acuity
Retinal Implant
Electrical stimulation

Additional relevant MeSH terms:
Choroideremia
Retinitis
Retinitis Pigmentosa
Eye Diseases, Hereditary
Eye Diseases
Choroid Diseases
Uveal Diseases
Genetic Diseases, Inborn
Genetic Diseases, X-Linked
Retinal Diseases
Retinal Dystrophies
Retinal Degeneration

ClinicalTrials.gov processed this record on July 22, 2014