Clinical trial NCT05433766: Patient-centred Smartphone AI for Protecting Vision in Macular Disease
Official title: Exploring the Feasibility of the OKKO Health App to Monitor and Predict the Decline in Vision Caused by Age-related Macular Degeneration
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Age-Related Macular Degeneration
Lead sponsor: OKKO Health
Sponsor class: INDUSTRY
Collaborators: name: INNOVATEUK
name: Nottingham University Hospitals NHS Trust
name: Oxford University Hospitals NHS Trust
name: The Macular Society
First posted: 2022-06-27
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

Brief 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.

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 Currently unpublished data collected using the OKKO Health app highlights its acceptability when collecting visual acuity compared to gold standard techniques used in clinical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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in visual status
timeFrame: 12 months continuous use
Secondary outcomes:
measure: Impact of the OKKO Health app on Health literacy
timeFrame: 3-6 months of app use
measure: Patient engagement with OKKO Health app
timeFrame: 12 months continuous use
measure: To explore the correlation of varying demographic and lifestyle factors on AMD disease progression
timeFrame: 12 months continuous use
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Trust
Study officials:
affiliation: Nottingham University Hospitals NHS Trust
name: Alexander Foss, D.M
role: PRINCIPAL_INVESTIGATOR
References: