OKKO Health Hyperacuity, Contrast and Colour Game Validation in Age-related Macular Degeneration
1 other identifier
observational
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Nov 2022
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2022
CompletedFirst Posted
Study publicly available on registry
October 6, 2022
CompletedStudy Start
First participant enrolled
November 1, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2023
CompletedMarch 22, 2023
March 1, 2023
7 months
October 3, 2022
March 21, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
Visual acuity
Visual acuity collected in the OKKO Health app and via ETDRS chart
Day 1
Contrast sensitivity
Contrast sensitivity collected in the OKKO Health app and via Pelli Robson chart.
Day 1
Colour sensitivity
Colour sensitivity collected in the OKKO Health app and via City University colour test/Mollon-Reffin colour vision test.
Day 1
Secondary Outcomes (2)
Visual distortion
Day 1
Optical coherence tomography (OCT)
Day 1
Eligibility Criteria
People with dry or wet age-related macular degeneration.
You may qualify if:
- Participants with AMD in at least one eye
- Willing to travel to the clinic in Exmouth/Bristol
- Able to hold and use a smartphone
You may not qualify if:
- Significant ocular pathology other than AMD
- Unable to provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- OKKO Healthlead
Study Sites (1)
Bristol
Bristol, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jamie Kawadler, PhD
OKKO Health
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2022
First Posted
October 6, 2022
Study Start
November 1, 2022
Primary Completion
June 1, 2023
Study Completion
June 1, 2023
Last Updated
March 22, 2023
Record last verified: 2023-03