Evoked Retinal Response

Not Applicable

Terminated

• Conditions: Retinitis Pigmentosa
• Interventions: Procedure: Ultrasound Stimulus

• Registration Number: NCT01415453
• Lead Sponsor: Columbia University

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 Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-07-25
• Study First Submitted QC: 2011-08-10
• Study First Posted: 2011-08-12
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Results First Submitted: 2012-06-21
• Status Verified: 2013-03
• Results First Submitted QC: 2013-03-01
• Last Update Submitted: 2013-03-01
• Results First Posted: 2013-04-05
• Last Update Posted: 2013-04-05

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• retinitis pigmentosa
• legally blind in at least one eye

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Exclusion Criteria

• unable to lay down on an exam table

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retinitis Pigmentosa	Ultrasound Stimulus	Subject will have retinitis pigmentosa and will be legally blind in one or both eyes

Primary Outcome Measures

Name	Time	Method
Phosphene Perception in Response to Ultrasound Pulse.	Subjects will undergo a single examination of approximately 15 minute duration during which they will report perception of phosphenes during ultrasound exposure.	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.

Trial Locations

Locations (1)

Columbia University Medical Center; 🇺🇸 New York, New York, United States