Evoked Retinal Response

This study has been terminated.

(Poor enrollment.)

Sponsor:

Information provided by (Responsible Party):

Ronald H. Silverman, Columbia University

ClinicalTrials.gov Identifier:

NCT01415453

First received: July 25, 2011

Last updated: March 1, 2013

Last verified: March 2013

History of Changes

Purpose

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

Condition	Intervention
Retinitis Pigmentosa	Procedure: Ultrasound Stimulus

Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label
Official Title:	Evoked Visual Response Using Pulsed Ultrasound

Resource links provided by NLM:

Genetics Home Reference related topics: Lenz microphthalmia syndrome oculofaciocardiodental syndrome Peters plus syndrome retinitis pigmentosa X-linked juvenile retinoschisis

U.S. FDA Resources

Further study details as provided by Columbia University:

Primary Outcome Measures:

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.

Enrollment:	1
Study Start Date:	July 2011
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Retinitis Pigmentosa Subject will have retinitis pigmentosa and will be legally blind in one or both eyes	Procedure: Ultrasound Stimulus Short pulses of focused ultrasound will be directed at spots on the retinal surface. Other Name: pulsed ultrasound

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.

Eligibility

Ages Eligible for Study:	18 Years to 60 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

retinitis pigmentosa
legally blind in at least one eye

Exclusion Criteria:

unable to lay down on an exam table

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01415453

Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

Investigators

Principal Investigator:

Ronald H Silverman, PhD

Columbia University

More Information

No publications provided

Responsible Party:	Ronald H. Silverman, Professor of Ophthalmic Science, Columbia University
ClinicalTrials.gov Identifier:	NCT01415453 History of Changes
Other Study ID Numbers:	AAAI1650
Study First Received:	July 25, 2011
Results First Received:	June 21, 2012
Last Updated:	March 1, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Columbia University:

retinitis pigmentosa
acoustic radiation force ultrasound
RP
visual field loss
Photoreceptor

Vision loss
retina
progressive vision loss
ultrasound

Additional relevant MeSH terms:

Retinitis
Retinitis Pigmentosa
Retinal Diseases
Eye Diseases

Eye Diseases, Hereditary
Retinal Dystrophies
Retinal Degeneration
Genetic Diseases, Inborn

ClinicalTrials.gov processed this record on May 19, 2013

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