Visual Remapping to Aid Reading With Field Loss
Primary Purpose
Age-related Macular Degeneration
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Traditional Remapping
Personalized Remapping
Sponsored by
About this trial
This is an interventional treatment trial for Age-related Macular Degeneration focused on measuring Scotoma, Remapping, Reading, Low vision, Visual aid
Eligibility Criteria
Inclusion Criteria:
- 16 years or older
- Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
- Stable fixation (+/- 1 deg) using their PRL.
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration achievable using eye tracker
Exclusion Criteria:
- Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
- Poor fixation (worse than+/- 1 deg) using their PRL.
- Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
- Satisfactory calibration not achievable using eye tracker
Sites / Locations
- University of MinnesotaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Patients with scotoma
Normally sighted with artificial scotoma
Arm Description
No remapping (control condition), traditional remapping, personalized remapping
No remapping (control condition), traditional remapping, personalized remapping
Outcomes
Primary Outcome Measures
Reading Speed for Individual Words
How quickly participants can correctly read displayed text
Reading Speed for Sentences
How quickly participants can correctly read displayed text
Reading Speed for Natural Text Samples
How quickly participants can correctly read displayed text
Reading error rate for Individual Words
How many mistakes participants make
Reading error rate for Sentences
How many mistakes participants make
Reading error rate for Natural Text Samples
How many mistakes participants make
Secondary Outcome Measures
Eye fixation quality for words
Variance of x and y eye position coordinates computed during fixation periods while reading
Eye fixation quality for sentences
Variance of x and y eye position coordinates computed during fixation periods while reading
Eye movement quality for sentences
Number off leftward (regressive) eye movements during sentence reading
Eye fixation quality for natural text samples
Variance of x and y eye position coordinates computed during fixation periods while reading
Eye movement quality for natural text samples
Number off leftward (regressive) eye movements during natural text reading
Full Information
NCT ID
NCT03848663
First Posted
January 28, 2019
Last Updated
March 6, 2023
Sponsor
University of Minnesota
1. Study Identification
Unique Protocol Identification Number
NCT03848663
Brief Title
Visual Remapping to Aid Reading With Field Loss
Official Title
Remapping the Visual Field to Aid Reading With Central Scotomas
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
November 30, 2024 (Anticipated)
Study Completion Date
November 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Scotoma, Remapping, Reading, Low vision, Visual aid
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
108 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patients with scotoma
Arm Type
Experimental
Arm Description
No remapping (control condition), traditional remapping, personalized remapping
Arm Title
Normally sighted with artificial scotoma
Arm Type
Active Comparator
Arm Description
No remapping (control condition), traditional remapping, personalized remapping
Intervention Type
Behavioral
Intervention Name(s)
Traditional Remapping
Intervention Description
Shifting text outside of scotoma
Intervention Type
Behavioral
Intervention Name(s)
Personalized Remapping
Intervention Description
Shifting text based on individual letter-based perimetry
Primary Outcome Measure Information:
Title
Reading Speed for Individual Words
Description
How quickly participants can correctly read displayed text
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
Title
Reading Speed for Sentences
Description
How quickly participants can correctly read displayed text
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
Title
Reading Speed for Natural Text Samples
Description
How quickly participants can correctly read displayed text
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
Title
Reading error rate for Individual Words
Description
How many mistakes participants make
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
Title
Reading error rate for Sentences
Description
How many mistakes participants make
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
Title
Reading error rate for Natural Text Samples
Description
How many mistakes participants make
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
Secondary Outcome Measure Information:
Title
Eye fixation quality for words
Description
Variance of x and y eye position coordinates computed during fixation periods while reading
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
Title
Eye fixation quality for sentences
Description
Variance of x and y eye position coordinates computed during fixation periods while reading
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
Title
Eye movement quality for sentences
Description
Number off leftward (regressive) eye movements during sentence reading
Time Frame
Measured during fourth visit
Title
Eye fixation quality for natural text samples
Description
Variance of x and y eye position coordinates computed during fixation periods while reading
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
Title
Eye movement quality for natural text samples
Description
Number off leftward (regressive) eye movements during natural text reading
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
16 years or older
Central vision loss of at least 5 deg diameter, including the fovea, from bilateral central scotomas
Stable fixation (+/- 1 deg) using their PRL.
No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
Satisfactory calibration achievable using eye tracker
Exclusion Criteria:
Central vision loss of less than 5 deg diameter; scotomas that do not cover the fovea; unilateral scotomas
Poor fixation (worse than+/- 1 deg) using their PRL.
Cognitive impairment as indicated by a Mini-Mental State Examination (MMSE).
Satisfactory calibration not achievable using eye tracker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Stephen Engel, Ph.D.
Phone
612-625-5571
Email
engel@umn.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Gordon Legge, Ph.D.
Email
legge@umn.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Engel, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephen Engel
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Once results are published.
IPD Sharing Access Criteria
Research group.
Learn more about this trial
Visual Remapping to Aid Reading With Field Loss
We'll reach out to this number within 24 hrs