Device for Age-related Macular Degeneration (AMD)

NCT06178978 | Completed DMC

• 1 other identifier: HUM00187177
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

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).

Conditions

Age-Related Macular Degeneration

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• National Eye Institute Visual function questionnaire (NEI VFQ 25)

  immediate during a single office visit - generally 5- 15 minutes

• Participant Experience Survey

  immediate during a single office visit - generally 5- 15 minutes

Study Arms (1)

Age-related macular degeneration

Patients with age-related macular degeneration.

Device: KalEYEdoscope

Interventions

KalEYEdoscope DEVICE

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.

Age-related macular degeneration

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

age-related macular degeneration

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

University of Michigan Kellogg Eye Center

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Yannis Paulus, M.D.

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Department of Ophthalmology and Visual Sciences

Study Record Dates

• First Submitted: August 24, 2023
• First Posted: December 21, 2023
• Study Start: March 10, 2022
• Primary Completion: March 25, 2022
• Study Completion: March 25, 2022
• Last Updated: December 21, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)