Patient-centred Smartphone AI for Protecting Vision in Macular Disease

Age-Related Macular Degeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05433766
• Other study ID #: OKHR-06
• Status: Enrolling by invitation
• Start date: March 8, 2023
• Est. completion date: April 2024

Study information

• Verified date: December 2022
• Source: OKKO Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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 Currently unpublished data collected using the OKKO Health app highlights its acceptability when collecting visual acuity compared to gold standard techniques used in clinical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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 500
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Age-Related Macular Degeneration
• Macular Degeneration

Locations

Country	Name	City	State
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Oxford University Hospitals NHS Trust	Oxford

Sponsors (5)

Lead Sponsor	Collaborator
OKKO Health	INNOVATEUK, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, The Macular Society

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in visual status	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	Impact of the OKKO Health app on Health literacy	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
Secondary	Patient engagement with OKKO Health app	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
Secondary	To explore the correlation of varying demographic and lifestyle factors on AMD disease progression	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