Retinitis PigmentosaNCT03635645
Experimental and Clinical Studies of Retinal Stimulation
A study testing New visual processing unit (VPU) with asymmetric waveforms and New VPU with bipolar stimulation in people with Retinitis Pigmentosa, run by University of Michigan at 1 site in United States.
Trial summary
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants. Read more about this study
- Who is it for?
- Ages 25 to 89 years
- Conditions the study is for
- Retinitis Pigmentosa
- What is being tested?
- New visual processing unit (VPU) with asymmetric waveforms and New VPU with bipolar stimulation
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2017to 30 Oct 2023
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be implanted with an Argus II Retinal Prosthesis system.
- Have 5 or more electrodes that create a perception with stimulation.
- Must be willing and able to comply with the protocol testing requirements.
Who cannot join
- Subjects participating in another investigatory drug or device study
- Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48105
James Weiland, 661-713-4603, weiland@umich.edu
About this study
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
Read the detailed description
The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.
- Conditions
- Retinitis Pigmentosa
- Being tested
- New visual processing unit (VPU) with asymmetric waveforms, New VPU with bipolar stimulation
- Medical subject headings
- Retinitis Pigmentosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New visual processing unit (VPU) with asymmetric waveformsDevice
A VPU will apply asymmetric and symmetric stimulation pulses.
New VPU with bipolar stimulationDevice
A VPU will apply bipolar stimulus pulses.
| Study group | Role | What they receive |
|---|---|---|
| Retinal stimulation | Experimental | Alternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus. Receives: Device: New visual processing unit (VPU) with asymmetric waveforms; Device: New VPU with bipolar stimulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent change in stimulus thresholds
Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).
Measured: Baseline, 8 hours
Change in shape perception
As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.
Measured: Baseline, 8 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2018
- Study start30 Oct 2017
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Retinitis PigmentosaStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Responsible party
- Principal investigator, James Weiland, University of Michigan
- Investigators
- James Weiland, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03635645
- Sponsor's protocol ID
- HUM00122699
- Other IDs
- R01EY022931-05
- Status last verified
- Dec 2022
- First submitted
- 26 Jul 2018
- Last updated
- 14 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Experimental and Clinical Studies of Retinal Stimulation
- ClinicalTrials.gov ID
- NCT03635645
- Acronym / sponsor ID
- HUM00122699
- Conditions
- Retinitis Pigmentosa
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Eye Institute (NEI)
- Study start
- 30 Oct 2017 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2023 (estimated)
- First posted
- 17 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will evaluate new methods of retinal stimulation and training with the goal of improving the visual ability of retinal prosthesis participants.
Detailed description
The study will test new ways to make the retinal prosthesis visual perception easier with auditory-visual training and how to make the retinal prosthesis work better at perceiving shapes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Retinal stimulation | Experimental | Device: New visual processing unit (VPU) with asymmetric waveforms, Device: New VPU with bipolar stimulationAlternative stimulus patterns will be tested (vs. baseline). The intervention is the alternative stimulus pattern. The intervention will be tested only in the clinic vs. baseline. The subject will go home with baseline settings. The two alternative stimulus patterns to be tested are asymmetric waveforms and bipolar stimulus. |
Who may qualify
- Ages
- 25 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be implanted with an Argus II Retinal Prosthesis system.
- Have 5 or more electrodes that create a perception with stimulation.
- Must be willing and able to comply with the protocol testing requirements.
Key exclusion criteria (2 listed)
- Subjects participating in another investigatory drug or device study
- Any disease or condition that prevents understanding or communication of informed consent, study demands, and testing protocols.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| New visual processing unit (VPU) with asymmetric waveformsA VPU will apply asymmetric and symmetric stimulation pulses. | Device | Retinal stimulation |
| New VPU with bipolar stimulationA VPU will apply bipolar stimulus pulses. | Device | Retinal stimulation |
Primary outcome
Percent change in stimulus thresholds
Time frame: Baseline, 8 hours
Compare baseline threshold with threshold of modified stimulus parameters. Threshold is measured in microCoulumbs ( the product of stimulus duration and stimulus amplitude).
Change in shape perception
Time frame: Baseline, 8 hours
As measured by elongation ratio. The elongation ratio is the ratio of major axis length to minor axis length of an ellipse. Subjects will draw shapes on a touch screen and these shapes will be fit to an ellipse.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
James Weiland principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing New visual processing unit (VPU) with asymmetric waveforms and New VPU with bipolar stimulation in people with Retinitis Pigmentosa, run by University of Michigan at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact James Weiland (661-713-4603, weiland@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent change in stimulus thresholds (time frame: Baseline, 8 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.