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Poor enrollment.
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Retinitis Pigmentosa | Experimental | Subject will have retinitis pigmentosa and will be legally blind in one or both eyes |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ultrasound Stimulus | Procedure | Short pulses of focused ultrasound will be directed at spots on the retinal surface. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phosphene Perception in Response to Ultrasound Pulse. | 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. | Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ronald H Silverman, PhD | Columbia University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Columbia University Medical Center | New York | New York | 10032 | United States |
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.
Recruitment occurred at the Department of Ophthalmology, Columbia University Medical Center from July 2011 to June 2012.
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| ID | Title | Description |
|---|---|---|
| FG000 | Retinitis Pigmentosa | Subject will have retinitis pigmentosa and will be legally blind in one or both eyes |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Retinitis Pigmentosa | Subject will have retinitis pigmentosa and will be legally blind in one or both eyes |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Phosphene Perception in Response to Ultrasound Pulse. | 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. | Only one subject was examined. | Posted | Number | participants | Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure. |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Retinitis Pigmentosa | Subject will have retinitis pigmentosa and will be legally blind in one or both eyes |
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Difficulty in recruiting appropriate volunteers. Study terminated due to poor enrollment.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Ronald Silverman | Columbia University Medical Center | 2123055484 | rs3072@columbia.edu |
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| ID | Term |
|---|---|
| D012174 | Retinitis Pigmentosa |
| D014786 | Vision Disorders |
| ID | Term |
|---|---|
| D015785 | Eye Diseases, Hereditary |
| D005128 | Eye Diseases |
| D058499 | Retinal Dystrophies |
| D012162 | Retinal Degeneration |
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| ID | Term |
|---|---|
| D000069453 | Ultrasonic Waves |
| ID | Term |
|---|---|
| D013016 | Sound |
| D011840 | Radiation, Nonionizing |
| D011827 | Radiation |
| D055585 | Physical Phenomena |
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| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| 0 |
| 1 |
| 0 |
| 1 |
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| D012164 |
| Retinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |