Device for Age-related Macular Degeneration (AMD)

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).

Study Overview

• Status: Completed
• Conditions: Age-Related Macular Degeneration
• Intervention / Treatment: Device: KalEYEdoscope

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 Type: Observational
• Enrollment (Actual): 31

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • University of Michigan Kellogg Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

age-related macular degeneration

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Age-related macular degeneration; Patients with age-related macular degeneration.

Device: KalEYEdoscope; 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
National Eye Institute Visual function questionnaire (NEI VFQ 25)	Participants complete 25-question questionnaire about their visual function.	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.	immediate during a single office visit - generally 5- 15 minutes

Collaborators and Investigators

• Sponsor: University of Michigan
• Investigators: Principal Investigator: Yannis Paulus, M.D., University of Michigan

Study record dates

Study Major Dates

• Study Start (Actual): March 10, 2022
• Primary Completion (Actual): March 25, 2022
• Study Completion (Actual): March 25, 2022

Study Registration Dates

• First Submitted: August 24, 2023
• First Submitted That Met QC Criteria: December 11, 2023
• First Posted (Actual): December 21, 2023

Study Record Updates

• Last Update Posted (Actual): December 21, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: macular degeneration; AMD; age-related macular degeneration; Home monitoring
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration
• Other Study ID Numbers: HUM00187177

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: HIPAA compliant data sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No