Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV) (HETALCEV)

Head Mounted Eye Tracking Aide for Loss of Central Vision

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

Study Overview

• Status: Completed
• Conditions: Age-related Macular Degeneration
• Intervention / Treatment: Other: small scotoma using Head Mounted Display No re-mapping; Other: Large scotoma using Head Mounted Display PLUS re-mapping

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.

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • University _of_Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: small scotoma using Head Mounted Display No re-mapping; patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping	Other: small scotoma using Head Mounted Display No re-mapping; re-mapping software turned off; Other: Large scotoma using Head Mounted Display PLUS re-mapping; re-mapping software turned on
Active Comparator: Large scotoma using Head Mounted Display PLUS re-mapping; patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping	Other: small scotoma using Head Mounted Display No re-mapping; re-mapping software turned off; Other: Large scotoma using Head Mounted Display PLUS re-mapping; re-mapping software turned on

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reading speed	words/minute	5 years

Collaborators and Investigators

• Sponsor: University of Minnesota
• Investigators: Principal Investigator: Erik van Kuijk, MD, PhD, University of Minnesota

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: June 13, 2016
• First Submitted That Met QC Criteria: July 7, 2016
• First Posted (Estimated): July 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 20, 2024
• Last Update Submitted That Met QC Criteria: June 17, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Age-related Macular Degeneration; Central Scotoma; Head Mounted Display
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: 1603M84883

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: participants will be de-identified