Trial Outcomes & Findings for Evoked Retinal Response (NCT NCT01415453)
NCT ID: NCT01415453
Last Updated: 2013-04-05
Results Overview
The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.
TERMINATED
NA
1 participants
Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.
2013-04-05
Participant Flow
Recruitment occurred at the Department of Ophthalmology, Columbia University Medical Center from July 2011 to June 2012.
No significant events followed enrollment prior to group assignment. There was only one group in this study: people with retinitis pigmentosa who were legally blind.
Participant milestones
| Measure |
Retinitis Pigmentosa
Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
|
|---|---|
|
Overall Study
STARTED
|
1
|
|
Overall Study
Imaging Study
|
1
|
|
Overall Study
COMPLETED
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Evoked Retinal Response
Baseline characteristics by cohort
| Measure |
Retinitis Pigmentosa
n=1 Participants
Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
PRIMARY outcome
Timeframe: Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.Population: Only one subject was examined.
The investigators will test the hypothesis that compression of retinal nerves by ultrasound force will cause perception of light (phosphenes) in blind subjects lacking functioning photoreceptors (retinitis pigmentosa). With each of two 5 msec ARFI exposures, if the subject either perceived the spark of light (phosphene), then it was documented as a positive response; if they did not, it was marked as a negative response.
Outcome measures
| Measure |
Retinitis Pigmentosa
n=1 Participants
Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
|
|---|---|
|
Phosphene Perception in Response to Ultrasound Pulse.
Positive Evoked Response
|
0 participants
|
|
Phosphene Perception in Response to Ultrasound Pulse.
Negative Evoked Response
|
1 participants
|
Adverse Events
Retinitis Pigmentosa
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place