Clinical trial NCT01864486: Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinitis Pigmentosa
Cone Rod Dystrophy
Choroideremia
Lead sponsor: Science Corporation
Sponsor class: INDUSTRY
First posted: 2013-05-29
Enrollment: 20
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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


Eligibility 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

Primary outcomes:
measure: Number of Adverse Events as a Measure of Safety and Tolerability
timeFrame: Up to 18 month after implantation
Secondary outcomes:
measure: Probable benefit
timeFrame: Up to 18 months after implantation
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Medical University of Graz
city: Nantes
country: France
facility: Clinique Ophtalmologique du CHU de Nantes
city: Paris
country: France
facility: Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
city: Bonn
country: Germany
facility: Dept. of Ophthalmology, University of Bonn
city: Hamburg
country: Germany
facility: Klinik und Poliklinik für Augenheilkunde Hamburg-Eppendorf
Study officials:
References: