Status:
COMPLETED
Restoring Vision With the Intelligent Retinal Implant System (IRIS V1)in Patients With Retinal Dystrophy
Lead Sponsor:
Science Corporation
Conditions:
Retinitis Pigmentosa
Cone Rod Dystrophy
Eligibility:
All Genders
25+ years
Phase:
NA
Brief Summary
This study evaluates the safety and effectiveness of the Intelligent Retinal Implants System (IRIS V1)
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 13 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01864486
Start Date
April 1 2013
End Date
October 13 2017
Last Update
October 17 2017
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Medical University of Graz
Graz, Austria, 8036
2
Clinique Ophtalmologique du CHU de Nantes
Nantes, France, 44000
3
Hopital des Quinze Vingts/Fondation Ophtalmologique A. De Rothschild
Paris, France, 75012
4
Dept. of Ophthalmology, University of Bonn
Bonn, Germany, 53127