Age-Related Macular DegenerationNCT06178978
Device for Age-related Macular Degeneration (AMD)
An observational study of Age-Related Macular Degeneration, run by University of Michigan at 1 site in United States.
Trial summary
This study involves user acceptability and feedback of KalEYEdoscope, a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration (AMD). 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?
- KalEYEdoscope
- Type of treatment
- Medical device
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Mar 2022to 25 Mar 2022
- Phase
- Observational
- 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
Study population: age-related macular degeneration
Who may be able to join
- Any patient aged 18 years or older with age-related macular degeneration who is seen at the Kellogg Eye Center.
Who cannot join
- pregnant women, prisoners, severe cognitive impairment, and diagnoses (mental or neuromuscular disorders) which could preclude independent use of the device.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Kellogg Eye Center
Ann Arbor, Michigan, 48105
About this study
Official title: Device for Monitoring Age-related Macular Degeneration (AMD)
This study involves user acceptability and feedback of KalEYEdoscope, a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration (AMD).
Read the detailed description
This is a patient-experience study being conducted at the Kellogg Eye Center in Ann Arbor in the outpatient setting. Patients who agree to enroll in the study will test the device and provide user feedback via a questionnaire as well as complete questionnaires about their visual function. The preliminary study looks at the usability of using this device for monitoring of age-related macular degeneration, obtaining user feedback to enhance the design. In the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss.
To gather user feedback on a digital, non-invasive, handheld device in the outpatient AMD patient population, with the goal of developing a user-friendly, portable device to monitor AMD progression, this study assesses the usability, comfort, duration, ergonomics, and ease of use of the device among AMD patients in a single session.
Data collected during the test may include but is not limited to the length of the test, boot time, screen transition time. The participants will then fill out the Visual Function Questionnaire-25, the System Usability Scale (SUS), and may include targeted questions designed by the study team to evaluate the participant experience with the device and visual function.
- Conditions
- Age-Related Macular Degeneration
- Being tested
- KalEYEdoscope
- Keywords
- age-related macular degeneration, macular degeneration, AMD, Home monitoring
- Medical subject headings
- Macular Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KalEYEdoscopeDevice
KalEYEdoscope is a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration. In the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss.
This study was conducted at the Kellogg Eye Center in Ann Arbor. Participants in the outpatient setting who agreed to enroll in the study tested the device and provided user feedback via a questionnaire as well as completed questionnaires about their visual function. This study assessed the usability, comfort, duration, ergonomics, and ease of use of the device among AMD patients in a single session.
| Study group | Role | What they receive |
|---|---|---|
| Age-related macular degeneration | Patients with age-related macular degeneration. Receives: Device: KalEYEdoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
System usability scale
Obtain user feedback via a questionnaire and evaluate the usability of using this device.
Measured: immediate during a single office visit - generally 5- 15 minutes
Secondary outcomes (2)
National Eye Institute Visual function questionnaire (NEI VFQ 25)
Participants complete 25-question questionnaire about their visual function.
Measured: immediate during a single office visit - generally 5- 15 minutes
Participant Experience Survey
Participants complete 8 qualitative questions with a Likert scale about the device and using the device.
Measured: immediate during a single office visit - generally 5- 15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start10 Mar 2022
- Primary completion25 Mar 2022
- Study completion25 Mar 2022
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 MichiganThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yannis Paulus, University of Michigan
- Investigators
- Yannis Paulus, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06178978
- Sponsor's protocol ID
- HUM00187177
- Status last verified
- Dec 2023
- First submitted
- 24 Aug 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: HIPAA compliant data sharing
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Device for Monitoring Age-related Macular Degeneration (AMD)
- ClinicalTrials.gov ID
- NCT06178978
- Acronym / sponsor ID
- HUM00187177
- Conditions
- Age-Related Macular Degeneration
- Keywords
- age-related macular degeneration, macular degeneration, AMD, Home monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 25 Mar 2022 (actual)
- First posted
- 21 Dec 2023 (actual)
- 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.
This study involves user acceptability and feedback of KalEYEdoscope, a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration (AMD).
Detailed description
This is a patient-experience study being conducted at the Kellogg Eye Center in Ann Arbor in the outpatient setting. Patients who agree to enroll in the study will test the device and provide user feedback via a questionnaire as well as complete questionnaires about their visual function. The preliminary study looks at the usability of using this device for monitoring of age-related macular degeneration, obtaining user feedback to enhance the design. In the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss.
To gather user feedback on a digital, non-invasive, handheld device in the outpatient AMD patient population, with the goal of developing a user-friendly, portable device to monitor AMD progression, this study assesses the usability, comfort, duration, ergonomics, and ease of use of the device among AMD patients in a single session.
Data collected during the test may include but is not limited to the length of the test, boot time, screen transition time. The participants will then fill out the Visual Function Questionnaire-25, the System Usability Scale (SUS), and may include targeted questions designed by the study team to evaluate the participant experience with the device and visual function.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Age-related macular degeneration | – | Device: KalEYEdoscopePatients with age-related macular degeneration. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- age-related macular degeneration
Key inclusion criteria (1 listed)
- Any patient aged 18 years or older with age-related macular degeneration who is seen at the Kellogg Eye Center.
Key exclusion criteria (1 listed)
- pregnant women, prisoners, severe cognitive impairment, and diagnoses (mental or neuromuscular disorders) which could preclude independent use of the device.
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 |
|---|---|---|
| KalEYEdoscopeKalEYEdoscope is a digital, handheld device utilizing shape-discrimination hyperacuity to distinguish the severity of age-related macular degeneration. In the future, developing such a device for home monitoring of macular degeneration may increase access to timely treatment to prevent vision loss. This study was conducted at the Kellogg Eye Center in Ann Arbor. Participants in the outpatient setting who agreed to enroll in the study tested the device and provided user feedback via a questionnaire as well as completed questionnaires about their visual function. This study assessed the usability, comfort, duration, ergonomics, and ease of use of the device among AMD patients in a single session. | Device | Age-related macular degeneration |
Primary outcome
System usability scale
Time frame: immediate during a single office visit - generally 5- 15 minutes
Obtain user feedback via a questionnaire and evaluate the usability of using this device.
2 secondary outcomes
National Eye Institute Visual function questionnaire (NEI VFQ 25)
Time frame: immediate during a single office visit - generally 5- 15 minutes
Participant Experience Survey
Time frame: immediate during a single office visit - generally 5- 15 minutes
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 21 Dec 2023.
- Individual participant dataSharing planned: No. HIPAA compliant data sharing
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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.
Yannis Paulus, M.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by University of Michigan 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 1 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 21 Dec 2023. 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?
System usability scale (time frame: immediate during a single office visit - generally 5- 15 minutes). 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 21 Dec 2023.