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

March 21, 2023 updated by: OKKO Health

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People with dry or wet age-related macular degeneration.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OKKO Health

Investigators

  • Principal Investigator: Jamie Kawadler, PhD, OKKO Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2022

Primary Completion (Anticipated)

June 1, 2023

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 5, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Actual)

March 22, 2023

Last Update Submitted That Met QC Criteria

March 21, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OKHR-07

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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