- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00568243
Visual Motor Coordination
Background:
- The relation between eye movement and brain function is a subject of interest to the National Eye Institute.
- By comparing eye movement in healthy volunteers to research conducted on patients who have difficulty moving their eyes, the National Eye Institute hopes to develop and improve diagnostic procedures for people with eye diseases.
Objectives:
-The purpose of this study is to understand how we see visual patterns and how we move our eyes to see.
Eligibility:
Normal volunteers:
- must have no serious illnesses and must be 18 years of age or older
- are able to follow directions and pay attention to visual stimuli and respond as appropriate
- individuals with a history of eye or brain diseases, or previous eye or eye muscle surgery, are not allowed to participate in this study. Individuals who are currently using eye medications also are not eligible for the study.
Patients:
- who are 18 years of age or older
- are able to follow directions and pay attention to visual stimuli and respond as appropriate
Design:
- Participants will visit the National Eye Institute outpatient clinic for examination and testing.
- Participants will be screened with a medical history and eye examination (including eye pressure and eye movement tests).
Participants with healthy eyes will participate in eye movement testing experiments:
- One or more sessions lasting less than three hours each.
- Eye movements will be recorded with a video/infrared camera system.
- For the majority of the studies done under this protocol, only one or two sessions will be required. A few studies recording very small eye movements will require three or more sessions.
Study Overview
Status
Conditions
Detailed Description
Study Description: This natural history study will investigate eye movements and other responses to visual stimuli in normal individuals (normal volunteers) and patients. Normal adult volunteers will be recruited and will undergo an eye exam to assure that there are no visual system problems. . Volunteers will be studied in one or more sessions where eye movement, verbal, or hand movement responses are recorded in response to visual stimuli. Patients with diseases affecting the oculomotor or visual systems will also be recruited to help us better understand these systems and to help characterize their specific disease.
Objectives:
The objective is to study normal volunteers and patients for eye movement and other responses to visual stimuli with the goal of better understanding human vision and neural control of eye movements.
Endpoints:
The primary outcome measure is eye movement and other responses to visual stimuli.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Maryland
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Bethesda, Maryland, United States, 20892
- National Institutes of Health Clinical Center
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
- INCLUSION CRITERIA:
Inclusion Criteria for Normal Volunteers:
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- Participant must be a volunteer with no ocular, visual, or oculomotor problems.
- Participant must be 18 years old or older.
- Participant must be able to follow directions and actively pay attention to visual stimuli and respond as appropriate.
- For studies which use the contact lens, participant must be able to tolerate a contact lens in either one or both eyes.
Inclusion Criteria for Patients:
In order to be eligible to participate in this study, an individual must meet all of the following criteria
- Participant must be 18 years old or older.
- Participant must be able to follow directions and actively pay attention to visual stimuli and respond as appropriate.
- For studies which use the contact lens, participant must be able to tolerate a contact lens in either one or both eyes.
EXCLUSION CRITERIA:
Exclusion Criteria for Normal Volunteers:
An individual who meets any of the following criteria will be excluded from participation in this
study:
An individual who meets any of the following criteria will be excluded from participation in thisstudy:
- Participant has a history of ocular or visual diseases or diseases affecting the nervous system (including myasthenia, MS, etc.) or any diseases which might affect control of eye movements or affect vision.
- Participant has had prior eye or eye muscle surgery.
- Participant has a history of eye patching (amblyopia or lazy eye).
- Participant currently uses eye drops or ocular medications.
Exclusion Criteria for Patients:
An individual who meets any of the following criteria will be excluded from participation in this study:
1. Patient is unable to cooperate with testing, including sitting still while eye movements are recorded.
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
|---|
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Normal Volunteer
Healthy subjects without neurodegenerative diseases
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Patients
Subjects with neurodegenerative diseases
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
eye movement/responses to visual stimuli
Time Frame: one to many times depending if normal volunteer or patient and the number of trials required to achieve clean data for small eye movements.
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Analysis of eye movements to characterize basic processes (normal volunteers) and to judge disease progress (in patients)
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one to many times depending if normal volunteer or patient and the number of trials required to achieve clean data for small eye movements.
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Rich J Krauzlis, Ph.D., National Eye Institute (NEI)
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 080031
- 08-EI-0031
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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