Retinitis Pigmentosa
Conditions
Brief summary
The objective of this study is to evaluate the safety and efficacy of the retinal stimulation system by evaluating the data after chronic implantation.
Detailed description
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.
Interventions
DEVICEArgus 16 Retinal Stimulation System
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.
Sponsors
Second Sight Medical Products
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Confirmed history of retinal degenerative disease in the worse seeing eye with remaining vision no better than light perception. The fellow eye can have any visual acuity but must have better vision than the eye that will have the surgery. * History of former useful form vision in worse-seeing eye * Acceptable ability to describe visual percepts * Age eighteen (18) or older
Exclusion criteria
* History of glaucoma * Optic neuropathy or other confirmed damage to optic nerve or visual cortical damage * Presence of communicable disease/infection * Pregnancy * History of claustrophobia * Inconsistent flash detection thresholds * Any other diseases that can effect the function of the retina * Subjects with a Beck Depression Inventory Interpretation score of \>30 and subsequent diagnosis of depression by a psychiatrist. * Corneal degeneration
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Adverse Events From 2 Weeks Post-op Until the End of the Study | From 2 weeks post-op until end of device usage, up to 10 years. | All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications. |
Countries
United States
Participant flow
Recruitment details
Recruitment began in February 2002. The last subject of 6 was enrolled in June 2004.
Participants by arm
| Arm | Count |
|---|---|
| Treatment Arm Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells. | 6 |
| Total | 6 |
Baseline characteristics
| Characteristic | Treatment Arm |
|---|---|
| Age, Continuous | 65 years STANDARD_DEVIATION 9.2 |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 2 Participants |
| Visual Acuity Bare Light Perception | 4 Participants |
| Visual Acuity No Light Perception | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 6 |
| other Total, other adverse events | 4 / 6 |
| serious Total, serious adverse events | 4 / 6 |
Outcome results
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.
Time frame: From 2 weeks post-op until end of device usage, up to 10 years.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Argus 16 Retinal Stimulation System | Number of Adverse Events From 2 Weeks Post-op Until the End of the Study | 34 total number of AEs |