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

Age-related Macular Degeneration Clinical Trial

— HETALCEV  

Official title:

Head Mounted Eye Tracking Aide for Loss of Central Vision

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02829606
• Other study ID #: 1603M84883
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: May 2024

Study information

• Verified date: June 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2024
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Age-related Macular Degeneration
• Macular Degeneration

Intervention

Other:
• small scotoma using Head Mounted Display No re-mapping
re-mapping software turned off
• Large scotoma using Head Mounted Display PLUS re-mapping
re-mapping software turned on

Locations

Country	Name	City	State
United States	University _of_Minnesota	Minneapolis	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reading speed	words/minute	5 years