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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

United States1 site
  • VAMC, Decatur

    Decatur, Georgia

Other trials in United States

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.

  1. First posted16 Mar 2001 (estimated)
  2. Study startJan 2000
  3. Study completionSep 2003

Resources

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
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

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.

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