Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV) (HETALCEV)
Primary Purpose
Age-related Macular Degeneration
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
small scotoma using Head Mounted Display No re-mapping
Large scotoma using Head Mounted Display PLUS re-mapping
Sponsored by
About this trial
This is an interventional supportive care trial for Age-related Macular Degeneration focused on measuring Age-related Macular Degeneration, Central Scotoma, Head Mounted Display
Eligibility Criteria
Inclusion Criteria:
- 18 years or older
- Central vision loss from bilateral central scotomas
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)
Exclusion Criteria:
- Failed MMSE
Sites / Locations
- University _of_Minnesota
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
small scotoma using Head Mounted Display No re-mapping
Large scotoma using Head Mounted Display PLUS re-mapping
Arm Description
patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping
patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping
Outcomes
Primary Outcome Measures
Reading speed
words/minute
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02829606
Brief Title
Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)
Acronym
HETALCEV
Official Title
Head Mounted Eye Tracking Aide for Loss of Central Vision
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2016 (Actual)
Primary Completion Date
April 1, 2023 (Actual)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
A device has been developed that has eye trackers integrated within the Head Mounted Display (HMD) and can remap text and images around the scotoma in real time to prevent information loss from a central scotoma. It can also carry out other types of image processing such as contrast enhancement and image magnification. The aim of this study is to assess the efficacy of this device on the visual performance of participants suffering from central vision loss, with and without remapping
Detailed Description
Participants with bilateral central scotomas will be selected for this study during their routine clinical visits at the University of Minnesota Eye Clinic. Written consent will be obtained from all participants.
Each participant will have their scotomas mapped using a Nidek MP-1 microperimeter housed in the psychology department to give exact size and shape information. This allows for the extent of each eye's scotoma to be put into the remapping software, and their intersection used in remapping calculation. Comparisons will be made between participants with small scotoma, less than 5 degrees, and participants with large scotoma, larger than 5 degrees. Experiments to be performed with the device are also divided into two categories. Category 1 involves reading of naturalistic text, and everyday task performance. Category 2 involves studying the effects of practice with the device on performance in category 1 experiments.
Participants will schedule an initial one-hour session for testing. During testing, participants will be told about the device and its functionality. Main instructions include what patients can expect to experience and see when wearing the HMD. Following this, the participants will be instructed on how to wear the HMD. If they have any glasses/ corrective lenses, they can be kept on. Once the patients don the HMD, testing will begin.
Initially, a calibration-free mode will be tested. This will entail asking the subject to focus on a particular point on the screen and checking if the gaze point determined by the eye tracker corresponds to this point. If good calibration is obtained, the investigators proceed with testing. Otherwise, a 3-point calibration sequence will be initiated following instructions on the software program. For the 3-point calibration sequence, the participant will be instructed to fixate at 3-5 different points on the screen one at a time. Following this calibration sequence, testing will resume and visual performance such as reading speed in words/minute will be measured as the primary outcome measure, with and without remapping.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Age-related Macular Degeneration
Keywords
Age-related Macular Degeneration, Central Scotoma, Head Mounted Display
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
small scotoma using Head Mounted Display No re-mapping
Arm Type
Active Comparator
Arm Description
patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping
Arm Title
Large scotoma using Head Mounted Display PLUS re-mapping
Arm Type
Active Comparator
Arm Description
patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping
Intervention Type
Other
Intervention Name(s)
small scotoma using Head Mounted Display No re-mapping
Intervention Description
re-mapping software turned off
Intervention Type
Other
Intervention Name(s)
Large scotoma using Head Mounted Display PLUS re-mapping
Intervention Description
re-mapping software turned on
Primary Outcome Measure Information:
Title
Reading speed
Description
words/minute
Time Frame
5 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years or older
Central vision loss from bilateral central scotomas
No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)
Exclusion Criteria:
Failed MMSE
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erik van Kuijk, MD, PhD
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
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
participants will be de-identified
Learn more about this trial
Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)
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