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

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ClinicalTrials.gov Identifier: NCT02829606
Recruitment Status : Recruiting
First Posted : July 12, 2016
Last Update Posted : January 27, 2020
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

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

Condition or disease Intervention/treatment Phase
Age-related Macular Degeneration Other: small scotoma using Head Mounted Display No re-mapping Other: Large scotoma using Head Mounted Display PLUS re-mapping Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Head Mounted Eye Tracking Aide for Loss of Central Vision
Actual Study Start Date : April 2016
Estimated Primary Completion Date : May 2023
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Reading speed [ Time Frame: 5 years ]
    words/minute



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02829606


Contacts
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Contact: Wendy Elasky, BS, CCRP 612-626-3056 waelasky@umn.edu

Locations
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United States, Minnesota
University _of_Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Wendy Elasky, BS, CCRP    612-626-3056    waelasky@umn.edu   
Sponsors and Collaborators
University of Minnesota
Investigators
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Principal Investigator: Erik van Kuijk, MD, PhD University of Minnesota

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT02829606    
Other Study ID Numbers: 1603M84883
First Posted: July 12, 2016    Key Record Dates
Last Update Posted: January 27, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: participants will be de-identified
Keywords provided by University of Minnesota:
Age-related Macular Degeneration
Central Scotoma
Head Mounted Display
Additional relevant MeSH terms:
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Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases