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Visual Remapping to Aid Reading With Field Loss

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ClinicalTrials.gov Identifier: NCT03848663
Recruitment Status : Not yet recruiting
First Posted : February 21, 2019
Last Update Posted : February 5, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Tracking Information
First Submitted Date  ICMJE January 28, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date February 5, 2020
Estimated Study Start Date  ICMJE May 1, 2020
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • Reading Speed for Individual Words [ Time Frame: Measured during third visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How quickly participants can correctly read displayed text
  • Reading Speed for Sentences [ Time Frame: Measured during fourth visit- each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How quickly participants can correctly read displayed text
  • Reading Speed for Natural Text Samples [ Time Frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How quickly participants can correctly read displayed text
  • Reading error rate for Individual Words [ Time Frame: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How many mistakes participants make
  • Reading error rate for Sentences [ Time Frame: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How many mistakes participants make
  • Reading error rate for Natural Text Samples [ Time Frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    How many mistakes participants make
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 18, 2019)
  • Eye fixation quality for words [ Time Frame: Measured during third visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    Variance of x and y eye position coordinates computed during fixation periods while reading
  • Eye fixation quality for sentences [ Time Frame: Measured during fourth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    Variance of x and y eye position coordinates computed during fixation periods while reading
  • Eye movement quality for sentences [ Time Frame: Measured during fourth visit ]
    Number off leftward (regressive) eye movements during sentence reading
  • Eye fixation quality for natural text samples [ Time Frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    Variance of x and y eye position coordinates computed during fixation periods while reading
  • Eye movement quality for natural text samples [ Time Frame: Measured during fifth visit; each visit is one day only and this measure refers to data gathered during a < 1 hr long reading session during that day ]
    Number off leftward (regressive) eye movements during natural text reading
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Visual Remapping to Aid Reading With Field Loss
Official Title  ICMJE Remapping the Visual Field to Aid Reading With Central Scotomas
Brief Summary Reading performance in patients with Central Vision Loss and age matched controls with artificial scotomas will be measured with and without different kinds of remapping of missing text to different parts of the visual field.
Detailed Description

Following initial characterization of their visual field loss, the participant's performance in reading tasks will be measured with and without remapping. Tasks will include reading groups of random letters, words, simple sentences, and "natural" text from the environment (taken from phone apps, signage, etc). Different kinds of remappings will be used by participants, including traditional and personalized remapping. For control observers, differently shaped artificial scotomas will be used.

Participants interested in the study will be brought in for an initial visit. All participants will be administered the MMSE. Observers who pass the criteria for the study will then have the remainder of the procedures described to them verbally prior to undergoing the remainder of the consent process (see below). Participants will then undergo a standard exam at the UMN eye clinic, if they have not had one within the last month.

Participants will then have their scotomas mapped using a microperimeter housed in the psychology department to give size and shape information. Additional perimetry may also be conducted using either of the two displays (either HMD or desk mounted computer monitor) we have developed. Here, patients will be asked to fixate at a spot on screen and identify visual stimuli presented at different regions of the screen. The size and locations of visual stimuli patients were unable to identify will provide the size and location of the scotoma. Another additional manual perimetry protocol may be conducted as well. This would involve asking subjects to fixate at the center of a tangent screen, and asking them to identify dots temporarily presented on the screen by the researcher using a laser pointer. The locations of dots that patients are unable to identify will provide the size and location of the scotoma. The location and extent of each eye's scotoma and PRL will be used as software inputs on either device. Perimetry using one or all of the methods above will be performed until acceptable information about the scotoma extent and location is obtained.

In a second visit, participants will perform the visual tasks that are used as the basis of their personalized remapping, letter perimetry. Participants will first view and report three randomly selected horizontally arranged letters placed at different locations in the visual field. This letter perimetry task will take about 40 min and will cover a large part of the visual field.

Participants will then read single words whose letters have been displaced from horizontal in various ways that comprise candidate remappings generated on the basis of the letter perimetry results. This personalization test will take about 40 minutes, and will find a good remapping strategy for the individual. Subjects will then be introduced to the reading tasks that comprise the remainder of the study

In 6 additional sessions, participants will perform various reading tasks using different remappings. In all of these, text will be displayed on the screen, and the task is simply to read aloud what was presented. Two sessions will involve reading single words, one session will involve reading strings of 3 letters that are not arranged horizontally, two sessions will involve reading short sentences, and one session will involve reading naturalistic text (from phone apps, signage, menus, etc). In all sessions, some reading will be with remapping, some will be without. Both traditional and personalized remapping will be used.

In all these sessions, the eye tracker will be calibrated to participants' individual head and eye position. This will involve fixating at different points on the device screen (HMD or desk-mounted) as the eye is imaged by the eye trackers. This may take up to 45 minutes in the initial session, if various combinations of head and eye positions are required for the eye trackers to work well. But once completed, calibration is much faster in subsequent sessions. Quick perimetry validation may also be conducted in each session.

Throughout all testing, patients will be asked if they feel any discomfort, and will be able to take a break or quit testing at any point.

Including the initial visit, testing for any given patient is anticipated to last no more than eight sessions over eight weeks. Enrolling participants, testing, and data analysis for all participants is anticipated to take five years from the date of enrollment of the first participant.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Age-related Macular Degeneration
Intervention  ICMJE
  • Behavioral: Traditional Remapping
    Shifting text outside of scotoma
  • Behavioral: Personalized Remapping
    Shifting text based on individual letter-based perimetry
Study Arms  ICMJE
  • Experimental: Patients with scotoma
    No remapping (control condition), traditional remapping, personalized remapping
    Interventions:
    • Behavioral: Traditional Remapping
    • Behavioral: Personalized Remapping
  • Active Comparator: Normally sighted with artificial scotoma
    No remapping (control condition), traditional remapping, personalized remapping
    Interventions:
    • Behavioral: Traditional Remapping
    • Behavioral: Personalized Remapping
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 Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: February 18, 2019)
108
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 30, 2024
Estimated Primary Completion Date November 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. 16 years or older
  2. Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
  3. Stable fixation (+/- 1 deg) using their PRL.
  4. No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  5. Satisfactory calibration achievable using eye tracker

Exclusion Criteria:

  1. Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
  2. Poor fixation (worse than+/- 1 deg) using their PRL.
  3. Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
  4. Satisfactory calibration not achievable using eye tracker
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Stephen Engel, Ph.D. 612-625-5571 engel@umn.edu
Contact: Gordon Legge, Ph.D. legge@umn.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03848663
Other Study ID Numbers  ICMJE REMAP002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Perimetry, psychophysical and eye-tracking data will be deidentified upon acquisition, and indexed using only a subject code. These data will be stored on a secure server for sharing upon request by a PI of a research team. We will offer psychophysical and eye tracking data along with appropriate metadata specifying details of the test (remapping used, stimulus protocol, etc) and data format.
Supporting Materials: Study Protocol
Supporting Materials: Analytic Code
Time Frame: Once results are published.
Access Criteria: Research group.
Responsible Party University of Minnesota
Study Sponsor  ICMJE University of Minnesota
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Stephen Engel, Ph.D. University of Minnesota
PRS Account University of Minnesota
Verification Date February 2020

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