Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects.
This chronic feasibility study will evaluate the ability of subjects to resolve multiple percepts and patterns under various stimulus conditions and optimize the effectiveness of electrical stimulus parameters with an initial chronic design.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm study | Experimental | Argus 16 Retinal Stimulation System-single arm study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Argus 16 Retinal Stimulation System | Device | The chronic retinal stimulation system is an implantable electronic device designed to provide electrical stimulation of the retina in order to elicit visual percepts in blind subjects. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Adverse Events From 2 Weeks Post-op Until the End of the Study | All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications. | From 2 weeks post-op until end of device usage, up to 10 years. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Lisa Olmos, MD | Doheny Eye Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Doheny Eye Institute | Los Angeles | California | 90033 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32131056 | Derived | Yue L, Wuyyuru V, Gonzalez-Calle A, Dorn JD, Humayun MS. Retina-electrode interface properties and vision restoration by two generations of retinal prostheses in one patient-one in each eye. J Neural Eng. 2020 Apr 9;17(2):026020. doi: 10.1088/1741-2552/ab7c8f. | |
| 22110084 | Derived | Nanduri D, Fine I, Horsager A, Boynton GM, Humayun MS, Greenberg RJ, Weiland JD. Frequency and amplitude modulation have different effects on the percepts elicited by retinal stimulation. Invest Ophthalmol Vis Sci. 2012 Jan 20;53(1):205-14. doi: 10.1167/iovs.11-8401. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Recruitment began in February 2002. The last subject of 6 was enrolled in June 2004.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Argus 16 Retinal Stimulation System | Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Arm | Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Adverse Events From 2 Weeks Post-op Until the End of the Study | All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications. | Posted | Number | total number of AEs | From 2 weeks post-op until end of device usage, up to 10 years. |
|
|
10 years
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Argus 16 Retinal Stimulation System | Single arm study in which all patients receive a device to stimulate retinal (eye) cells. The treatment is intended to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal Detachment | Eye disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Array Rotation | Eye disorders | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jessy Dorn, PhD, Director, Clinical and Scientific Research | Second Sight Medical Products, Inc. | 8188335089 | jdorn@secondsight.com |
Not provided
| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
Not provided
Not provided
Subjects with a confirmed history of advanced retinal degenerative disease and meeting the inclusion criteria listed will be considered as eligible participants in the study. Subjects who have a condition listed in the exclusion criteria will not be allowed to participate in the study. Eligible subjects with the above diagnoses will be recruited from the Doheny Eye Institute at the University of Southern California. Additionally, new subjects encountered in the clinic who fulfill the inclusion criteria will also be eligible to participate. Upon meeting the entry criteria, all subjects must sign an Informed Consent prior to enrollment in the study. Since the subjects are blind, an individual not associated with this study must read the informed consent to the subject. This person must sign the consent form as a witness to the informed consent process.
Not provided
Not provided
Not provided
Not provided
| 21296811 | Derived | Eng JG, Agrawal RN, Tozer KR, Ross-Cisneros FN, Dagnelie G, Greenberg RJ, Chader GJ, Weiland JD, Rao NA, Sadun AA, Humayun MS. Morphometric analysis of optic nerves and retina from an end-stage retinitis pigmentosa patient with an implanted active epiretinal array. Invest Ophthalmol Vis Sci. 2011 Jun 28;52(7):4610-6. doi: 10.1167/iovs.09-4936. |
| 20720224 | Derived | Horsager A, Boynton GM, Greenberg RJ, Fine I. Temporal interactions during paired-electrode stimulation in two retinal prosthesis subjects. Invest Ophthalmol Vis Sci. 2011 Feb 1;52(1):549-57. doi: 10.1167/iovs.10-5282. Print 2011 Jan. |
| 19608533 | Derived | Greenwald SH, Horsager A, Humayun MS, Greenberg RJ, McMahon MJ, Fine I. Brightness as a function of current amplitude in human retinal electrical stimulation. Invest Ophthalmol Vis Sci. 2009 Nov;50(11):5017-25. doi: 10.1167/iovs.08-2897. Epub 2009 Jul 15. |
| 19365014 | Derived | Caspi A, Dorn JD, McClure KH, Humayun MS, Greenberg RJ, McMahon MJ. Feasibility study of a retinal prosthesis: spatial vision with a 16-electrode implant. Arch Ophthalmol. 2009 Apr;127(4):398-401. doi: 10.1001/archophthalmol.2009.20. |
| 19098313 | Derived | Horsager A, Greenwald SH, Weiland JD, Humayun MS, Greenberg RJ, McMahon MJ, Boynton GM, Fine I. Predicting visual sensitivity in retinal prosthesis patients. Invest Ophthalmol Vis Sci. 2009 Apr;50(4):1483-91. doi: 10.1167/iovs.08-2595. Epub 2008 Dec 20. |
| 18515576 | Derived | de Balthasar C, Patel S, Roy A, Freda R, Greenwald S, Horsager A, Mahadevappa M, Yanai D, McMahon MJ, Humayun MS, Greenberg RJ, Weiland JD, Fine I. Factors affecting perceptual thresholds in epiretinal prostheses. Invest Ophthalmol Vis Sci. 2008 Jun;49(6):2303-14. doi: 10.1167/iovs.07-0696. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Visual Acuity | Count of Participants | Participants | No |
|
|
| 2 |
| 6 |
| 4 |
| 6 |
| 4 |
| 6 |
| Endophthalmitis | Eye disorders | Systematic Assessment |
|
| Conjunctival Erosion | Eye disorders | Systematic Assessment |
|
| Dizziness | Eye disorders | Systematic Assessment |
|
| Glaucoma | Eye disorders | Systematic Assessment |
|
| Mesenteric Ischemia | Gastrointestinal disorders | Systematic Assessment |
|
| Re-Tack | Eye disorders | Systematic Assessment | as a result of bump to the head |
|
| Conjunctivitis | Eye disorders | Systematic Assessment |
|
| Corneal Dryness | Eye disorders | Systematic Assessment |
|
| Corneal Opacity | Eye disorders | Systematic Assessment |
|
| Epiretinal Membrane | Eye disorders | Systematic Assessment |
|
| Headache | Eye disorders | Systematic Assessment |
|
| Headache and Nausea | Eye disorders | Systematic Assessment |
|
| Inflammation | Eye disorders | Systematic Assessment |
|
| Numbness | Eye disorders | Systematic Assessment |
|
| Ocular Pain | Eye disorders | Systematic Assessment |
|
| Pain and Nausea | Eye disorders | Systematic Assessment |
|
| Bump | General disorders | Systematic Assessment |
|
| Chest Pain | Cardiac disorders | Systematic Assessment |
|
| Dizziness | Eye disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Fall (with array movement) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Inflammation | General disorders | Systematic Assessment |
|
| Minor Injury (right cheekbone) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Mild Trauma To Head | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Sprained Right Wrist | Injury, poisoning and procedural complications | Systematic Assessment | Motor vehicle accident |
|
| Ocular Pain | Eye disorders | Systematic Assessment |
|
| Rash | General disorders | Systematic Assessment |
|
| Rash (Fluorescein Dye Reaction) | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Transient Ischemic Attack | Vascular disorders | Systematic Assessment |
|
| Vertigo | General disorders | Systematic Assessment |
|
Separate IP agreement.
| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |