Clincosm LogoSign in Get a demo

OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration

Sponsor
OKKO Health (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05569226
Collaborator
(none)
50
Enrollment
1
Location
3
Anticipated Duration (Months)
16.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Smartphone apps have the potential to measure standard metrics of visual function. In addition, new tests may serve as digital biomarkers to detect early progression of disease, assess risk of developing disease or expand the patient's clinical picture. Smartphones are inherently advantageous to reduce the reliance on specialist bulky and costly equipment that currently only exists in specialist clinics. While there are some smartphone apps available for vision monitoring, very few have any clinical evidence to support reliability, validity and diagnostic accuracy.

The OKKO Health app (www.okkohealth.com) is a smartphone app available on Apple iOS and Android platforms, consisting of short games with applied vision science technology to measure visual function in an engaging way. The app has one game per function, each on average 1-2 minutes. There are 4 game modes available testing visual acuity, contrast sensitivity, colour sensitivity and hyperacuity. This study will aim to validate these measures of visual function against gold standard clinical tests.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration
    Actual Study Start Date :
    Nov 1, 2022
    Anticipated Primary Completion Date :
    Feb 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2023

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [Day 1]

      Visual acuity collected in the OKKO Health app and via ETDRS chart

    2. Contrast sensitivity [Day 1]

      Contrast sensitivity collected in the OKKO Health app and via Pelli Robson chart.

    3. Colour sensitivity [Day 1]

      Colour sensitivity collected in the OKKO Health app and via City University colour test/Mollon-Reffin colour vision test.

    Secondary Outcome Measures

    1. Visual distortion [Day 1]

      Visual distortion assessed using the OKKO Health app and Amsler chart.

    2. Optical coherence tomography (OCT) [Day 1]

      Scans obtained from OCT.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Inclusion Criteria:

    • Participants with AMD in at least one eye

    • Willing to travel to the clinic in Exmouth/Bristol

    • Able to hold and use a smartphone

    Exclusion Criteria:

    • Significant ocular pathology other than AMD

    • Unable to provide written informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Bristol Bristol United Kingdom

    Sponsors and Collaborators

    • OKKO Health

    Investigators

    • Principal Investigator: Jamie Kawadler, PhD, OKKO Health

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    OKKO Health
    ClinicalTrials.gov Identifier:
    NCT05569226
    Other Study ID Numbers:
    • OKHR-07
    First Posted:
    Oct 6, 2022
    Last Update Posted:
    Nov 17, 2022
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Macular Degeneration

    Study Results

    No Results Posted as of Nov 17, 2022