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

This study is currently recruiting participants. (see Contacts and Locations)
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
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: 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 August 28, 2014