Patient-centred Smartphone AI for Protecting Vision in Macular Disease

March 8, 2023 updated by: OKKO Health

Exploring the Feasibility of the OKKO Health App to Monitor and Predict the Decline in Vision Caused by Age-related Macular Degeneration

Macular disease is the leading cause of blindness in the UK and age-related macular degeneration must undergo monitoring to determine if an injection into the eye is required that month [required in 50% of visits] - these patients are the 'frequent fliers' within ophthalmology units, visiting specialist hospital clinics on a monthly or bi-monthly basis. This project aims to create a home-monitoring algorithm that could in the future, enable the movement of 'monitoring' of chronic eye disease into the patients' homes: remotely identifying who does need an in-person appointment, and who can safely stay away from hospital.

Study Overview

Status

Enrolling by invitation

Conditions

Detailed Description

The OKKO Health application is a CE-marked medical software application that aims to monitor visual function, track symptoms and treatment, and improve patient knowledge about their condition.

To monitor visual function, OKKO implements quick and engaging activities to assess visual function, contrast sensitivity, and hyperacuity. The aim of this is to develop the app to see if it is possible to detect changes in visual function in a timely manner. This would enable regular monitoring for disease progression and/or the response of visual function to treatments between clinical visits. Home monitoring may reveal information that may support the early diagnosis of worsening conditions and may enable a greater understanding of disease progression or stabilisation. Currently unpublished data collected using the OKKO Health app highlights its acceptability when collecting visual acuity compared to gold standard techniques used in clinical practice.

OKKO includes self-monitoring features which may result in an increased (disease) awareness including vision changes between clinic visits. OKKO offers symptom and treatment tracking functionality as well as education modules to increase literacy about the disease and treatment. These elements may improve the patient's self-efficacy, enable patient empowerment, and may increase the involvement of patients in their care and more thorough communication with ophthalmologists including shared decision-making processes. Thus, these psychological and behavioural changes may alleviate the patient's burden.

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

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

Study Locations

  • United Kingdom
      • Nottingham, United Kingdom, NG7 2UH
        • Nottingham University Hospitals NHS Trust
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Trust

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

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adults with macular degeneration undergoing anti-VEGF treatment, at either Queens Medical Centre, Nottingham University Hospitals NHS Trust or Oxford Eye Hospital at Oxford University Hospitals NHS Trust will be considered for this study.

Description

Inclusion Criteria:

  • Patients newly diagnosed with wet (neovascular) AMD in at least on eye at the start of their anti-VGEF treatment.
  • Participants with wet AMD in at least one eye undergoing anti-VGEF therapy.

  • Access to a device running a compatible software

    • Apple device running iOS 12 or later,
    • Android devices running Android 7.0 or later,
  • Ability to read and understand English.
  • Willing and able to provide informed consent.

Exclusion Criteria:

  • Vision worse than 6/60 or 1.0 LogMAR in both eyes.
  • Significant cognitive impairment.
  • Patients who do not have the manual dexterity to tap a screen.

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: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual status
Time Frame: 12 months continuous use
Generate an algorithm to detect a change in visual status (in particular a deterioration) in advance of in-person hospital appointment.
12 months continuous use

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of the OKKO Health app on Health literacy
Time Frame: 3-6 months of app use
The HLS-EU-Q16, a validated questionnaire, will be used to assess Health Literacy at baseline and following 3-6 months of app use.
3-6 months of app use
Patient engagement with OKKO Health app
Time Frame: 12 months continuous use
Patient engagement will be determined through an analyses of engagement collected within the OKKO Health. Volunteers will be asked to use the OKKO Health app three times per week.
12 months continuous use
To explore the correlation of varying demographic and lifestyle factors on AMD disease progression
Time Frame: 12 months continuous use
This will include identifying the correlation between the trend in the OKKO Health app data versus lifestyle data (this will include physical activity (steps taken, distance walked) and sleep recorded through the participants device). Correlations between health data (BMI and blood pressure) and OKKO Health trend data will also be calculated.
12 months continuous use

Collaborators and Investigators

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

Sponsor

OKKO Health

Collaborators

Nottingham University Hospitals NHS Trust
Oxford University Hospitals NHS Trust
INNOVATEUK
The Macular Society

Investigators

  • Principal Investigator: Alexander Foss, D.M, Nottingham University Hospitals NHS Trust

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)

March 8, 2023

Primary Completion (Anticipated)

April 1, 2024

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 22, 2022

First Posted (Actual)

June 27, 2022

Study Record Updates

Last Update Posted (Estimate)

March 10, 2023

Last Update Submitted That Met QC Criteria

March 8, 2023

Last Verified

December 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OKHR-06

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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