Clinical trial NCT02829606: Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)
Official title: Head Mounted Eye Tracking Aide for Loss of Central Vision
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Age-related Macular Degeneration
Keywords: Age-related Macular Degeneration
Central Scotoma
Head Mounted Display
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Reading speed
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University _of_Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Erik van Kuijk, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: