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

NCT ID: NCT02829606

Last Updated: 2024-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2024-05-31

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.

Conditions

Age-related Macular Degeneration

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

small scotoma using Head Mounted Display No re-mapping

patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping

Group Type: ACTIVE_COMPARATOR

small scotoma using Head Mounted Display No re-mapping

Intervention Type: OTHER

re-mapping software turned off

Large scotoma using Head Mounted Display PLUS re-mapping

Intervention Type: OTHER

re-mapping software turned on

Large scotoma using Head Mounted Display PLUS re-mapping

patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping

Group Type: ACTIVE_COMPARATOR

small scotoma using Head Mounted Display No re-mapping

Intervention Type: OTHER

re-mapping software turned off

Large scotoma using Head Mounted Display PLUS re-mapping

Intervention Type: OTHER

re-mapping software turned on

Interventions

small scotoma using Head Mounted Display No re-mapping

re-mapping software turned off

Intervention Type: OTHER

Large scotoma using Head Mounted Display PLUS re-mapping

re-mapping software turned on

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Minnesota

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Erik van Kuijk, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Minnesota

Locations

University _of_Minnesota

Minneapolis, Minnesota, United States

Countries

United States

Other Identifiers

1603M84883

Identifier Type: -

Identifier Source: org_study_id