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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
University of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
June 13, 2016
Last Updated
August 2, 2023
Sponsor
University of Minnesota
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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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