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Evaluation of Eye Movement Tracking Systems for Visual Rehabilitation

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ClinicalTrials.gov Identifier: NCT00013429
Recruitment Status : Completed
First Posted : March 16, 2001
Last Update Posted : January 21, 2009
Sponsor:
Information provided by:
VA Office of Research and Development

Tracking Information
First Submitted Date  ICMJE March 14, 2001
First Posted Date  ICMJE March 16, 2001
Last Update Posted Date January 21, 2009
Study Start Date  ICMJE January 2000
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of Eye Movement Tracking Systems for Visual Rehabilitation
Official Title  ICMJE Evaluation of Eye Movement Tracking Systems for Visual Rehabilitation
Brief 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. 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Blindness
Intervention  ICMJE Procedure: Visual
Study Arms  ICMJE Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE
 (submitted: June¬†23,¬†2005)
100
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE September 2003
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE Visually impaired
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00013429
Other Study ID Numbers  ICMJE C2102R
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE US Department of Veterans Affairs
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Investigator: John Fryer, Ph.D., Asst. Director Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
Investigator: Nancy Rocheleau, Program Analyst Department of Veterans Affairs, Program Analysis and Review Section (PARS), Rehabilitation Research & Development Service
PRS Account VA Office of Research and Development
Verification Date January 2001

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP