Healthy VolunteerNCT00568243
Visual Motor Coordination
An observational study of Healthy Volunteer and Neurodegenerative Diseases, run by National Eye Institute (NEI) at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Neurodegenerative Diseases
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Dec 2007to 9 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: normal adult volunteers and patients with eye movement problems including strabismus or neuro-degeneration.
Who may be able to join
- 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.
- In order to be eligible to participate in this study, an individual must meet all of the following criteria
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Show all 9Show fewer
- Participant currently uses eye drops or ocular medications.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Healthy Volunteer, Neurodegenerative Diseases
- Keywords
- Visuomotor Integration, Visual Attention, Eye Movements, Reaction Time, Natural History, Saccades, Healthy Volunteer, HV
- Medical subject headings
- Neurodegenerative Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal Volunteer | Healthy subjects without neurodegenerative diseases | |
| Patients | Subjects with neurodegenerative diseases |
What is being measured
The primary outcome is the main question the study is designed to answer.
eye movement/responses to visual stimuli
Analysis of eye movements to characterize basic processes (normal volunteers) and to judge disease progress (in patients)
Measured: one to many times depending if normal volunteer or patient and the number of trials required to achieve clean data for small eye movements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2007 (estimated)
- Study start4 Dec 2007
- Primary completion9 Apr 2024
- Study completion9 Apr 2024
Why it stopped: Low enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Eye Institute (NEI)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Rich J Krauzlis, Ph.D., Principal investigator, National Eye Institute (NEI)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00568243
- Sponsor's protocol ID
- 080031
- Other IDs
- 08-EI-0031
- Status last verified
- Apr 2024
- First submitted
- 4 Dec 2007
- Last updated
- 12 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: .The raw data is eye movement tracings which are of no utility except in the context of a study with multiple subjects. Obtained results will be published and if requested, original data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Visual Motor Coordination
- ClinicalTrials.gov ID
- NCT00568243
- Acronym / sponsor ID
- 080031
- Conditions
- Healthy Volunteer, Neurodegenerative Diseases
- Keywords
- Visuomotor Integration, Visual Attention, Eye Movements, Reaction Time, Natural History, Saccades, Healthy Volunteer, HV
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Low enrollment
- Enrolment
- 34 participants (actual)
- Lead sponsor
- National Eye Institute (NEI)US National Institutes of Health
- Study start
- 4 Dec 2007 (actual)
- Primary completion
- 9 Apr 2024 (actual)
- Study completion
- 9 Apr 2024 (actual)
- First posted
- 5 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal Volunteer | – | –Healthy subjects without neurodegenerative diseases |
| Patients | – | –Subjects with neurodegenerative diseases |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- normal adult volunteers and patients with eye movement problems including strabismus or neuro-degeneration.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (9 listed)
- An individual who meets any of the following criteria will be excluded from participation in this
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
Analysis of eye movements to characterize basic processes (normal volunteers) and to judge disease progress (in patients)
Results and safety
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: No. .The raw data is eye movement tracings which are of no utility except in the context of a study with multiple subjects. Obtained results will be published and if requested, original data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rich J Krauzlis, Ph.D. principal investigator
National Eye Institute (NEI)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteer and Neurodegenerative Diseases, run by National Eye Institute (NEI) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Low enrollment). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Apr 2024.