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Device for Age-related Macular Degeneration (AMD)

Device for Monitoring Age-related Macular Degeneration (AMD)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06178978
Enrollment
31
Registered
2023-12-21
Start date
2022-03-10
Completion date
2022-03-25
Last updated
2023-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

Keywords

age-related macular degeneration, macular degeneration, AMD, Home monitoring

Brief 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).

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.

Interventions

DEVICEKalEYEdoscope

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.

Sponsors

University of Michigan
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Any patient aged 18 years or older with age-related macular degeneration who is seen at the Kellogg Eye Center.

Exclusion criteria

* pregnant women, prisoners, severe cognitive impairment, and diagnoses (mental or neuromuscular disorders) which could preclude independent use of the device.

Design outcomes

Primary

MeasureTime frameDescription
System usability scaleimmediate during a single office visit - generally 5- 15 minutesObtain user feedback via a questionnaire and evaluate the usability of using this device.

Secondary

MeasureTime frameDescription
National Eye Institute Visual function questionnaire (NEI VFQ 25)immediate during a single office visit - generally 5- 15 minutesParticipants complete 25-question questionnaire about their visual function.
Participant Experience Surveyimmediate during a single office visit - generally 5- 15 minutesParticipants complete 8 qualitative questions with a Likert scale about the device and using the device.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026