Device for Age-related Macular Degeneration (AMD)

Completed

• Conditions: Age-Related Macular Degeneration
• Interventions: Device: KalEYEdoscope

• Registration Number: NCT06178978
• Lead Sponsor: University of Michigan

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.

Study Timeline

• Study Start: 2022-03-10
• Primary Completion: 2022-03-25
• Study Completion: 2022-03-25
• Study First Submitted: 2023-08-24
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-11
• Last Update Submitted: 2023-12-11
• Study First Posted: 2023-12-21
• Last Update Posted: 2023-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Age-related macular degeneration	KalEYEdoscope	Patients with age-related macular degeneration.

Primary Outcome Measures

Name	Time	Method
System usability scale	immediate during a single office visit - generally 5- 15 minutes	Obtain user feedback via a questionnaire and evaluate the usability of using this device.

Secondary Outcome Measures

Name	Time	Method
Participant Experience Survey	immediate during a single office visit - generally 5- 15 minutes	Participants complete 8 qualitative questions with a Likert scale about the device and using the device.
National Eye Institute Visual function questionnaire (NEI VFQ 25)	immediate during a single office visit - generally 5- 15 minutes	Participants complete 25-question questionnaire about their visual function.

Trial Locations

Locations (1)

University of Michigan Kellogg Eye Center; 🇺🇸 Ann Arbor, Michigan, United States