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IRIS PILOT - Extended Pilot Study With a Retinal Implant System

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ClinicalTrials.gov Identifier: NCT00427180
Recruitment Status : Unknown
Verified March 2010 by Intelligent Medical Implants GmbH.
Recruitment status was:  Active, not recruiting
First Posted : January 26, 2007
Last Update Posted : March 3, 2010
Sponsor:
Information provided by:

Study Description
Brief 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.

Condition or disease Intervention/treatment
Retinitis Pigmentosa Cone-Rod Dystrophy Choroideremia Device: Retinal Implant System (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.


Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Extended Pilot Study to Evaluate Pattern Recognition With a Chronic Retinal Implant System
Study Start Date : December 2006
Estimated Primary Completion Date : November 2010
Estimated Study Completion Date : December 2010


Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 ( Other Identifier: IMI Intelligent Medical Implants GmbH )
SP-80-00-00-00-03-V01 ( Other Identifier: IMI Intelligent Medical Implants GmbH )
First Posted: January 26, 2007    Key Record Dates
Last Update Posted: March 3, 2010
Last Verified: March 2010

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
Cone-Rod Dystrophies
Retinal Diseases
Eye Diseases
Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn
Choroid Diseases
Uveal Diseases
Genetic Diseases, X-Linked