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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01415453
Other study ID # AAAI1650
Secondary ID
Status Terminated
Phase N/A
First received July 25, 2011
Last updated March 1, 2013
Start date July 2011
Est. completion date June 2012

Study information

Verified date March 2013
Source Columbia University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 1
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 60 Years
Eligibility Inclusion Criteria:

- retinitis pigmentosa

- legally blind in at least one eye

Exclusion Criteria:

- unable to lay down on an exam table

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
Ultrasound Stimulus
Short pulses of focused ultrasound will be directed at spots on the retinal surface.

Locations

Country Name City State
United States Columbia University Medical Center New York New York

Sponsors (1)

Lead Sponsor Collaborator
Columbia University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
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. Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure. No
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