NCT06241625

Brief Summary

To assess the usability, tolerability, and repeatability of the set of VR headset-based tasks.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 20, 2022

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 5, 2024

Status Verified

August 1, 2023

Enrollment Period

1.3 years

First QC Date

January 5, 2023

Last Update Submit

February 1, 2024

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

  • Usability, tolerability and repeatability

    The primary objective of this study is to assess the usability, tolerability, and repeatability of the set of VR headset-based tasks. To assess the usability and tolerability a patient survey is performed.

    20 minutes

Secondary Outcomes (1)

  • Contrast sensitivity function (CSF)

    10 minutes

Study Arms (1)

VR-Visual Function Test

EXPERIMENTAL

Assessment of virtual reality based vision function in Patients with AMD

Diagnostic Test: Virtual Reality (VR) Contrast Function Test

Interventions

Virtual Reality (VR) Contrast Function TestDIAGNOSTIC_TEST

Patients perform a new Virtual Reality (VR) Contrast Function Test

VR-Visual Function Test

Eligibility Criteria

Age50 Years - 105 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects ≥18 years of age diagnosed with AMD
  • Subject Snellen BCVA score is 20/100 or better
  • Ability to undergo quality optical coherence tomography (OCT) imaging
  • Willing and able to give written informed consent

You may not qualify if:

  • Unwilling to use headset
  • Previous negative experience with a VR headset (eg, motion sickness, discomfort)
  • Any known oculomotor impairment that would impact the ability of the subject to perform the tasks (eg, nystagmus, proptosis, apraxia of eyelid opening)
  • Any manifest neurological or cognitive condition that would impair the subject's understanding or performance on the test (eg, Alzheimer's disease, Parkinson's disease)
  • Any physical limitations that would prohibit the use of the VR headset (eg, neck problems)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Augenklinik Zurich West

Zurich, Canton of Zurich, 8047, Switzerland

RECRUITING

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Stephan Michels, MD

    Augenklinik Zurich West

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephan Michels, MD

CONTACT

+414454517info@augenklinik-zh.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 5, 2023

First Posted

February 5, 2024

Study Start

October 20, 2022

Primary Completion

February 1, 2024

Study Completion

July 1, 2024

Last Updated

February 5, 2024

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)