Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (IRIS-1)

This study is currently recruiting participants.
Verified May 2013 by Pixium Vision SA
Sponsor:
Information provided by (Responsible Party):
Pixium Vision SA
ClinicalTrials.gov Identifier:
NCT01864486
First received: May 15, 2013
Last updated: May 24, 2013
Last verified: May 2013
  Purpose

This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)


Condition Intervention
Retinitis Pigmentosa,
Cone Rod Dystrophy,
Choroideremia
Device: Intelligent Retinal Implant System

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy (Title in France: Compensation of Vision With the Intelligent Retinal Implant System (IRIS V1) in Patients With Retinal Dystrophy)

Resource links provided by NLM:


Further study details as provided by Pixium Vision SA:

Primary Outcome Measures:
  • Number of Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to 18 month after implantation ] [ Designated as safety issue: Yes ]
    All subjects undergo ophthalmological examinations in predefined intervals after implantation. Ophthalmological examinations include funduscopy, slit lamp examination and OCT. All adverse events are recorded and analysed.


Secondary Outcome Measures:
  • Probable benefit [ Time Frame: Up to 18 months after implantation ] [ Designated as safety issue: No ]
    A series of vision test including grating visual acuity, light localization and contrast sensitivity is performed before and after implantation of the device.


Estimated Enrollment: 20
Study Start Date: April 2013
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Intelligent Retinal Implant System Device: Intelligent Retinal Implant System

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Is 25 years or older at the date of enrolment
  • Has a confirmed diagnosis of retinitis pigmentosa, choroideremia or cone-rod dystrophy
  • Has a visual acuity of logMAR 2.3 or worse in both the eyes as determined by a Square Grating scale.
  • Has functional ganglion cells and optic nerve activity
  • Has a memory of former useful form vision
  • Understands and accepts the obligation to present for all schedule follow-up visits.
  • Has AP eye dimensions that are appropriate with the dimensions of the implant(In Germany: Has an AP eye dimension between 20.5 and 25 mm)
  • Has head dimensions that are appropriate for visual Interface.

Exclusion Criteria:

  • Has a history of severe glaucoma, uveitis, optic neuropathy or any confirmed damage to the optic nerve and/or visual cortex,
  • Has any disease (other than study allowed diseases) or condition that affects retinal function of the study eye (e.g., central retinal artery/vein occlusion, end-stage diabetic retinopathy, current or prior retinal detachment, infectious or inflammatory retinal disease, etc.),
  • Has any disease or condition that prevents adequate visualization of the retina of the study eye including, but not limited to, corneal degeneration that cannot be resolved prior to implantation,
  • Has any disease or condition of the anterior segment of the study eye that prevents adequate physical examination (e.g., ocular trauma, etc.),
  • Has severe nystagmus,
  • Has any ocular condition that leads him or her to eye rubbing,
  • Has any disease or condition that precludes the understanding or communication of the informed consent, study requirements or test protocols (e.g., deafness , multiple sclerosis, amyotrophc lateral sclerosis, neuritis, etc),
  • Has a history of epileptic seizure,
  • Has a history of chronic or recurrent infection or inflammation that would preclude participation in the study,
  • Has a known sensitivity to the contact materials of the implant,
  • Presents with hypotony in the study eye,
  • Presents with hypertony in the study eye,
  • Is pregnant or lactating,
  • Has another active implanted device (e.g. cochlear implant) or any form of metallic implant in the head (other than dental work) that may interfere with the device function,
  • Has a diagnosis requiring an active implant (e.g., cardiac pacemaker, vagus nerve implant, etc.),
  • Has active cancer or a history of intraocular, optic nerve or brain cancer and metastasis,
  • Is an immune-suppressed subject (e.g., due to HIV positive diagnosis, etc.),
  • Is carrier of multi-resistant germs,
  • Requires the use of any of the following medications:

    • Antimetabolites,
    • Thrombocyte aggregation reducing therapies (10 days prior until 3 days after surgery),
    • Oral anticoagulants (5 days before until 3 days after surgery),
  • Is participating in another investigational drug or device study that may interfere with the proposed treatment or the ensuring follow-up schedule, (in Germany: Is participating in another investigational drug or device study)
  • Has any health concern that makes general anaesthesia inadvisable, (in Germany: Patients with an ASA-Score of 3 or higher are excluded from the study)
  • Is likely requiring MRI scans subsequent to implantation and prior to explantation,
  • Is likely requiring therapeutic ultrasound subsequent to implantation and prior to explantation of the Retinal Implant

In Germany: - Patients with recurrent or chronic inflammations or infections are excluded from the study. Specifically patients with the following disorders are excluded:

  • Common inflammation - severe chronic and consuming diseases that frequently associated with infection (e.g. Crohn disease, Whipple's disease)
  • Chronic inflammation of the skin in the area of the eye (e.g. dermatitis, rosacea, infection of the skin, herpes zoster)
  • Chronic inflammation in the area of the eye (e.g. herpes of cornea and/or conjunctiva, recurrent blepharoconjunctivitis, horedolum, chalazion) In Germany: - Has a severe psychological disorder. When in any doubt, an expert assessment needs to be arranged to clarify whether the patient's psychological health is suitable for the trial.

In Germany: - Has severe renal, cardiac, hepatic etc. organ diseases

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01864486

Locations
Austria
Medical University of Graz Recruiting
Graz, Austria, 8036
Contact: Michaela Velikay-Parel, Prof.    +43 316 385 3817    michaela.velikayparel@meduni-graz.at   
Principal Investigator: Michaela Velikay-Parel, Prof.         
France
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild Recruiting
Paris, France, 75012
Contact: Yannick LeMer, Dr.    +33 1 480 366 71    ylemer@fo-rothschild.fr   
Principal Investigator: Yannick LeMer, Dr.         
Germany
Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Gisbert Richard, Prof.    +49 40 42803 2301    augenklinik@uke.uni-hamburg.de   
Principal Investigator: Gisbert Richard, Prof.         
Sponsors and Collaborators
Pixium Vision SA
  More Information

No publications provided

Responsible Party: Pixium Vision SA
ClinicalTrials.gov Identifier: NCT01864486     History of Changes
Other Study ID Numbers: CP4M
Study First Received: May 15, 2013
Last Updated: May 24, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Germany: Federal Institute for Drugs and Medical Devices
Germany: Ethics Commission
Austria: Federal Office for Safety in Health Care
Austria: Ethikkommission

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

ClinicalTrials.gov processed this record on April 15, 2014