Evoked Retinal Response
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 25, 2011 | ||||
| Last Updated Date | March 1, 2013 | ||||
| Start Date ICMJE | July 2011 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Phosphene Perception in Response to Ultrasound Pulse. [ Time Frame: Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure. ] [ Designated as safety issue: No ] 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. |
||||
| Original Primary Outcome Measures ICMJE |
Phosphene perception in response to ultrasound pulse. [ Time Frame: Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure. ] [ Designated as safety issue: No ] 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). |
||||
| Change History | Complete list of historical versions of study NCT01415453 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evoked Retinal Response | ||||
| Official Title ICMJE | Evoked Visual Response Using Pulsed Ultrasound | ||||
| Brief Summary | Retinitis pigmentosa (RP) is the name given to a group of inherited eye diseases that affect the retina (the light-sensitive part of the eye). RP causes the breakdown of photoreceptor cells (cells in the retina that detect light). Photoreceptor cells capture and process light helping us to see. As these cells breakdown and die, people experience progressive vision loss. There is no known cure for retinitis pigmentosa. The investigators have observed that short pulses of focused ultrasound can cause perception of light when directed to spots on the retinal surface. The investigators propose to conduct a study to determine if pulsed ultrasound will stimulate the perception of light in the absence of functional photoreceptors in people with RP |
||||
| Detailed Description | Patients affected by retinitis pigmentosa (RP) and related diseases suffer loss of vision due to death of photoreceptor cells. The investigators have observed that short pulses of focused ultrasound can cause perception of light (phosphenes) when directed to spots on the retinal surface. If this phenomenon is caused by direct stimulation of the retinal nerves, which seems probable, then it might be possible to use this phenomenon to produce a form of vision in such patients. The investigators propose to conduct a study of a small cohort of patients affected by RP to determine if pulsed ultrasound will evoke a perception of light in the absence of functional photoreceptors. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label |
||||
| Condition ICMJE | Retinitis Pigmentosa | ||||
| Intervention ICMJE | Procedure: Ultrasound Stimulus
Short pulses of focused ultrasound will be directed at spots on the retinal surface.
Other Name: pulsed ultrasound |
||||
| Study Arm (s) | Experimental: Retinitis Pigmentosa
Subject will have retinitis pigmentosa and will be legally blind in one or both eyes
Intervention: Procedure: Ultrasound Stimulus |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Terminated | ||||
| Enrollment ICMJE | 1 | ||||
| Completion Date | June 2012 | ||||
| Primary Completion Date | June 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01415453 | ||||
| Other Study ID Numbers ICMJE | AAAI1650 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Ronald H. Silverman, Columbia University | ||||
| Study Sponsor ICMJE | Columbia University | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Columbia University | ||||
| Verification Date | March 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||