Clinical trial NCT06178978: Device for Age-related Macular Degeneration (AMD)
Official title: Device for Monitoring Age-related Macular Degeneration (AMD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Age-Related Macular Degeneration
Keywords: age-related macular degeneration
macular degeneration
AMD
Home monitoring
Lead sponsor: University of Michigan
Sponsor class: OTHER
First posted: 2023-12-21
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: age-related macular degeneration

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.

Eligibility criteria: 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.

Primary outcomes:
measure: System usability scale
timeFrame: immediate during a single office visit - generally 5- 15 minutes
Secondary outcomes:
measure: National Eye Institute Visual function questionnaire (NEI VFQ 25)
timeFrame: immediate during a single office visit - generally 5- 15 minutes
measure: Participant Experience Survey
timeFrame: immediate during a single office visit - generally 5- 15 minutes
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Kellogg Eye Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Yannis Paulus, M.D.
role: PRINCIPAL_INVESTIGATOR
References: