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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05569226

Enrollment

Registered

2022-10-06

Start date

2022-11-01

Completion date

2023-06-01

Last updated

2023-03-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Age-Related Macular Degeneration

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Visual acuity	Day 1	Visual acuity collected in the OKKO Health app and via ETDRS chart
Contrast sensitivity	Day 1	Contrast sensitivity collected in the OKKO Health app and via Pelli Robson chart.
Colour sensitivity	Day 1	Colour sensitivity collected in the OKKO Health app and via City University colour test/Mollon-Reffin colour vision test.

Secondary

Measure	Time frame	Description
Visual distortion	Day 1	Visual distortion assessed using the OKKO Health app and Amsler chart.
Optical coherence tomography (OCT)	Day 1	Scans obtained from OCT.

Countries

United Kingdom

Contacts

Primary ContactJoe Antoun

joe@okkohealth.com07951092744

Outcome results