Evoked Retinal Response

NCT01415453 | Terminated Results

• 1 other identifier: AAAI1650
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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

Conditions

Retinitis Pigmentosa

Keywords

retinitis pigmentosa; acoustic radiation force ultrasound; RP; visual field loss; Photoreceptor; Vision loss; retina; progressive vision loss; ultrasound

Outcome Measures

Primary Outcomes (1)

• 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.

Study Arms (1)

Retinitis Pigmentosa

EXPERIMENTAL

Subject will have retinitis pigmentosa and will be legally blind in one or both eyes

Procedure: Ultrasound Stimulus

Interventions

Ultrasound Stimulus PROCEDURE

Short pulses of focused ultrasound will be directed at spots on the retinal surface.

Also known as: pulsed ultrasound

Retinitis Pigmentosa

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• retinitis pigmentosa
• legally blind in at least one eye

You may not qualify if:

• unable to lay down on an exam table

Sponsors & Collaborators

• Columbia University: lead

Study Sites (1)

Columbia University Medical Center

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

Retinitis Pigmentosa; Vision Disorders

Interventions

Ultrasonic Waves

Condition Hierarchy (Ancestors)

Eye Diseases, Hereditary; Eye Diseases; Retinal Dystrophies; Retinal Degeneration; Retinal Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Limitations and Caveats

Difficulty in recruiting appropriate volunteers. Study terminated due to poor enrollment.

Results Point of Contact

• Title: Dr Ronald Silverman
• Organization: Columbia University Medical Center

rs3072@columbia.edu

2123055484

Study Officials

• Ronald H Silverman, PhD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Ophthalmic Science

Study Record Dates

• First Submitted: July 25, 2011
• First Posted: August 12, 2011
• Study Start: July 1, 2011
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: April 5, 2013
• Results First Posted: April 5, 2013

Record last verified: 2013-03

Locations

US (1)