BlindnessPhase 2NCT00013429
Evaluation of Eye Movement Tracking Systems for Visual Rehabilitation
A Phase 2 study testing Visual in people with Blindness, run by US Department of Veterans Affairs at 1 site in United States.
Trial summary
The project objective is to validate the types of eye trackers that may most effectively be employed in the rehabilitation evaluation and training of people with central scotomas. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Blindness
- What is being tested?
- Visual
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2000to Sep 2003
- Phase
- Phase 2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Visually impaired
Trial locations and contacts
1 site in 1 country.
About this study
The project objective is to validate the types of eye trackers that may most effectively be employed in the rehabilitation evaluation and training of people with central scotomas. The eye trackers will include the three basic types of eye trackers, namely, 1)electrophysical, 2) front surface trackers, and 3) retinal trackers.
Read the detailed description
The project objective is to validate the types of eye trackers that may most effectively be employed in the rehabilitation evaluation and training of people with central scotomas. The eye trackers will include equipment representing the three basic types of eye trackers, namely, 1) electrophysical (e.g., electrooculogram or EOG), 2) front surface trackers (e.g. pupil), and 3) retinal trackers (e.g. SLO). The most appropriate eye tracking system for evaluation and training will depend on the type of eye movements (i.e., fixations, saccades, and pursuits) that comprise the complex eye movements used for visual skills (e.g., spotting, localization, scanning, tracing, tracking) which are being evaluated/trained for visually guided activities of daily living (e.g., reading, face recognition and television watching).
The following methods will be employed. First, a Scanning Laser Ophthalmoscope (SLO) will be employed to confirm that people with central scotomas are recruited from the Atlanta VA Eye Clinic and the VA Rehab R\&D Subject Registry. SLO data taken for each eye will determine scotoma density, size and position. Visual functions of acuity, contrast sensitivity, and visual fields will be measured. Basic eye movements (e.g., fixation, tracking, saccades) and complex eye movements during visual tasks will be investigated to determine the effect of different biocular scotoma/PRL characteristics including: 1) central scotoma in one eye and functioning fovea in fellow eye, 2) central scotoma in both eyes and PRLs in retinal correspondence, and 3) central scotomas in both eyes with PRLs in anomalous retinal correspondence. Based on these biocular eye movement results, specifications can be developed for determining which eye can be used to monitor eye movements during binocular visual tasks (e.g., reading, face recognition, and TV event watching) as well as the need for biocular eye tracking equipment in evaluating complex eye movements. Each person will be tested using each representative eye tracker. The results of each eye tracker (position, velocity, and acceleration) in measuring PRL movements during fixation, saccade, and pursuit will be related to SLO measures. The results of these tests will also be compared to the types of measurements needed for evaluating complex eye movements in visual tasks. Specific measurements will be used to evaluate a patient's ability to perform the basic visual skills employed in performing everyday vision-related activities. The cost effectiveness of employing each type of eye tracker will be determined by a number of factors, including equipment cost, maintenance costs, ease of calibration and ease of use with low vision patients (e.g., feasibility for use with low vision patients who use head turns or optical low vision devices to view stimuli), and long-term reliability. Feasibility studies employing an eye tracker for eye movement monitoring during evaluations or biofeedback during training will be done in a few clinical studies (perimetry, PRL ability, visual scanning for reading training, and visual scanning for faces training) to indicate the potential clinical practicality of employing eye trackers for rehabilitative evaluation and training.
- Conditions
- Blindness
- Being tested
- Visual
- Keywords
- Vision, Opthalmology, blindness, aging
- Medical subject headings
- Blindness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VisualProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2001 (estimated)
- Study startJan 2000
- Study completionSep 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BlindnessStudies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Investigators
- John Fryer, Ph.D., Asst. Director, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development ServiceNancy Rocheleau, Program Analyst, Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00013429
- Sponsor's protocol ID
- C2102R
- Status last verified
- Jan 2001
- First submitted
- 14 Mar 2001
- Last updated
- 21 Jan 2009
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Eye Movement Tracking Systems for Visual Rehabilitation
- ClinicalTrials.gov ID
- NCT00013429
- Acronym / sponsor ID
- C2102R
- Conditions
- Blindness
- Keywords
- Vision, Opthalmology, blindness, aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Jan 2000
- Study completion
- Sep 2003 (actual)
- First posted
- 16 Mar 2001 (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.
The project objective is to validate the types of eye trackers that may most effectively be employed in the rehabilitation evaluation and training of people with central scotomas. The eye trackers will include the three basic types of eye trackers, namely, 1)electrophysical, 2) front surface trackers, and 3) retinal trackers.
Detailed description
The project objective is to validate the types of eye trackers that may most effectively be employed in the rehabilitation evaluation and training of people with central scotomas. The eye trackers will include equipment representing the three basic types of eye trackers, namely, 1) electrophysical (e.g., electrooculogram or EOG), 2) front surface trackers (e.g. pupil), and 3) retinal trackers (e.g. SLO). The most appropriate eye tracking system for evaluation and training will depend on the type of eye movements (i.e., fixations, saccades, and pursuits) that comprise the complex eye movements used for visual skills (e.g., spotting, localization, scanning, tracing, tracking) which are being evaluated/trained for visually guided activities of daily living (e.g., reading, face recognition and television watching).
The following methods will be employed. First, a Scanning Laser Ophthalmoscope (SLO) will be employed to confirm that people with central scotomas are recruited from the Atlanta VA Eye Clinic and the VA Rehab R\&D Subject Registry. SLO data taken for each eye will determine scotoma density, size and position. Visual functions of acuity, contrast sensitivity, and visual fields will be measured. Basic eye movements (e.g., fixation, tracking, saccades) and complex eye movements during visual tasks will be investigated to determine the effect of different biocular scotoma/PRL characteristics including: 1) central scotoma in one eye and functioning fovea in fellow eye, 2) central scotoma in both eyes and PRLs in retinal correspondence, and 3) central scotomas in both eyes with PRLs in anomalous retinal correspondence. Based on these biocular eye movement results, specifications can be developed for determining which eye can be used to monitor eye movements during binocular visual tasks (e.g., reading, face recognition, and TV event watching) as well as the need for biocular eye tracking equipment in evaluating complex eye movements. Each person will be tested using each representative eye tracker. The results of each eye tracker (position, velocity, and acceleration) in measuring PRL movements during fixation, saccade, and pursuit will be related to SLO measures. The results of these tests will also be compared to the types of measurements needed for evaluating complex eye movements in visual tasks. Specific measurements will be used to evaluate a patient's ability to perform the basic visual skills employed in performing everyday vision-related activities. The cost effectiveness of employing each type of eye tracker will be determined by a number of factors, including equipment cost, maintenance costs, ease of calibration and ease of use with low vision patients (e.g., feasibility for use with low vision patients who use head turns or optical low vision devices to view stimuli), and long-term reliability. Feasibility studies employing an eye tracker for eye movement monitoring during evaluations or biofeedback during training will be done in a few clinical studies (perimetry, PRL ability, visual scanning for reading training, and visual scanning for faces training) to indicate the potential clinical practicality of employing eye trackers for rehabilitative evaluation and training.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visual | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jan 2009.
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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.
John Fryer, Ph.D., Asst. Director
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Nancy Rocheleau, Program Analyst
Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Visual in people with Blindness, run by US Department of Veterans Affairs 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?
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: finished, as of the sponsor's last update on 21 Jan 2009. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 21 Jan 2009.