Trial Outcomes & Findings for Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa (NCT NCT00279500)
NCT ID: NCT00279500
Last Updated: 2023-04-12
Results Overview
All adverse events are collected as a result of chronic electrical stimulation and/or surgical complications.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
From 2 weeks post-op until end of device usage, up to 10 years.
Results posted on
2023-04-12
Participant Flow
Recruitment began in February 2002. The last subject of 6 was enrolled in June 2004.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
6
|
|
Overall Study
COMPLETED
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Feasibility Study of a Chronic Retinal Stimulator in Retinitis Pigmentosa
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=6 Participants
Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
|
|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 9.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Visual Acuity
No Light Perception
|
2 Participants
n=5 Participants
|
|
Visual Acuity
Bare Light Perception
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Argus 16 Retinal Stimulation System
n=6 Participants
Single arm study in which all patients were implanted with the Argus 16 Retinal Stimulation System, which stimulates retinal (eye) cells.
|
|---|---|
|
Number of Adverse Events From 2 Weeks Post-op Until the End of the Study
|
34 total number of AEs
|
Adverse Events
Argus 16 Retinal Stimulation System
Serious events: 4 serious events
Other events: 4 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Argus 16 Retinal Stimulation System
n=6 participants at risk
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.
|
|---|---|
|
Eye disorders
Retinal Detachment
|
33.3%
2/6 • Number of events 2 • 10 years
|
|
Eye disorders
Endophthalmitis
|
16.7%
1/6 • Number of events 3 • 10 years
|
|
Eye disorders
Conjunctival Erosion
|
33.3%
2/6 • Number of events 5 • 10 years
|
|
Eye disorders
Dizziness
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Glaucoma
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Gastrointestinal disorders
Mesenteric Ischemia
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Re-Tack
|
16.7%
1/6 • Number of events 1 • 10 years
|
Other adverse events
| Measure |
Argus 16 Retinal Stimulation System
n=6 participants at risk
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.
|
|---|---|
|
Eye disorders
Array Rotation
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Conjunctivitis
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Corneal Dryness
|
33.3%
2/6 • Number of events 2 • 10 years
|
|
Eye disorders
Corneal Opacity
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Epiretinal Membrane
|
16.7%
1/6 • Number of events 2 • 10 years
|
|
Eye disorders
Headache
|
16.7%
1/6 • Number of events 2 • 10 years
|
|
Eye disorders
Headache and Nausea
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Inflammation
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Numbness
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Ocular Pain
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Pain and Nausea
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
General disorders
Bump
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Cardiac disorders
Chest Pain
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Eye disorders
Dizziness
|
16.7%
1/6 • Number of events 2 • 10 years
|
|
Injury, poisoning and procedural complications
Fall
|
33.3%
2/6 • Number of events 3 • 10 years
|
|
Injury, poisoning and procedural complications
Fall (with array movement)
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
General disorders
Headache
|
50.0%
3/6 • Number of events 3 • 10 years
|
|
General disorders
Inflammation
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Minor Injury (right cheekbone)
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Mild Trauma To Head
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Sprained Right Wrist
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
General disorders
Rash
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Injury, poisoning and procedural complications
Rash (Fluorescein Dye Reaction)
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
Vascular disorders
Transient Ischemic Attack
|
16.7%
1/6 • Number of events 1 • 10 years
|
|
General disorders
Vertigo
|
16.7%
1/6 • Number of events 1 • 10 years
|
Additional Information
Jessy Dorn, PhD, Director, Clinical and Scientific Research
Second Sight Medical Products, Inc.
Phone: 8188335089
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Separate IP agreement.
- Publication restrictions are in place
Restriction type: OTHER