Age-related Macular DegenerationHETALCEVNCT02829606
Head Mounted Eye Tracking Aide for Loss of Central Vision (HETALCEV)
A study testing small scotoma using Head Mounted Display No re-mapping and Large scotoma using Head Mounted Display PLUS re-mapping in people with Age-related Macular Degeneration, run by University of Minnesota at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Age-related Macular Degeneration
- What is being tested?
- small scotoma using Head Mounted Display No re-mapping and Large scotoma using Head Mounted Display PLUS re-mapping
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2016to May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older
- Central vision loss from bilateral central scotomas
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)
Who cannot join
- Failed MMSE
Trial locations and contacts
1 site in 1 country.
United States1 site
University _of_Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: 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
Read the 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
- Being tested
- small scotoma using Head Mounted Display No re-mapping, Large scotoma using Head Mounted Display PLUS re-mapping
- Keywords
- Age-related Macular Degeneration, Central Scotoma, Head Mounted Display
- Medical subject headings
- Macular Degeneration, Scotoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
small scotoma using Head Mounted Display No re-mappingOther
re-mapping software turned off
Large scotoma using Head Mounted Display PLUS re-mappingOther
re-mapping software turned on
| Study group | Role | What they receive |
|---|---|---|
| small scotoma using Head Mounted Display No re-mapping | Active comparator | patients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping Receives: Other: small scotoma using Head Mounted Display No re-mapping; Other: Large scotoma using Head Mounted Display PLUS re-mapping |
| Large scotoma using Head Mounted Display PLUS re-mapping | Active comparator | patients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping Receives: Other: small scotoma using Head Mounted Display No re-mapping; Other: Large scotoma using Head Mounted Display PLUS re-mapping |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reading speed
words/minute
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2016 (estimated)
- Study startApr 2016
- Primary completion1 Apr 2023
- Study completionMay 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-related Macular DegenerationStudies of the same condition, open and under way.
- More trials run by University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Erik van Kuijk, MD, PhD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02829606
- Sponsor's protocol ID
- 1603M84883
- Acronym
- HETALCEV
- Status last verified
- Jun 2024
- First submitted
- 13 Jun 2016
- Last updated
- 20 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: participants will be de-identified
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Head Mounted Eye Tracking Aide for Loss of Central Vision
- ClinicalTrials.gov ID
- NCT02829606
- Acronym / sponsor ID
- HETALCEV / 1603M84883
- Conditions
- Age-related Macular Degeneration
- Keywords
- Age-related Macular Degeneration, Central Scotoma, Head Mounted Display
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- May 2024 (actual)
- First posted
- 12 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| small scotoma using Head Mounted Display No re-mapping | Active comparator | Other: small scotoma using Head Mounted Display No re-mapping, Other: Large scotoma using Head Mounted Display PLUS re-mappingpatients with scotoma smaller than 5 degrees NO re-mapping PLUS re-mapping |
| Large scotoma using Head Mounted Display PLUS re-mapping | Active comparator | Other: small scotoma using Head Mounted Display No re-mapping, Other: Large scotoma using Head Mounted Display PLUS re-mappingpatients with scotoma larger than 5 degrees NO re-mapping PLUS re-mapping |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older
- Central vision loss from bilateral central scotomas
- No cognitive impairment as indicated by a Mini-Mental State Examination (MMSE)
Key exclusion criteria (1 listed)
- Failed MMSE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| small scotoma using Head Mounted Display No re-mappingre-mapping software turned off | Other | Large scotoma using Head Mounted Display PLUS re-mapping, small scotoma using Head Mounted Display No re-mapping |
| Large scotoma using Head Mounted Display PLUS re-mappingre-mapping software turned on | Other | Large scotoma using Head Mounted Display PLUS re-mapping, small scotoma using Head Mounted Display No re-mapping |
Primary outcome
Reading speed
Time frame: 5 years
words/minute
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2024.
- Individual participant dataSharing planned: No. participants will be de-identified
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erik van Kuijk, MD, PhD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing small scotoma using Head Mounted Display No re-mapping and Large scotoma using Head Mounted Display PLUS re-mapping in people with Age-related Macular Degeneration, run by University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reading speed (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2024.