Patient-centred Smartphone AI for Protecting Vision in Macular Disease

NCT05433766 | Unknown

• 1 other identifier: OKHR-06
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Impact of the OKKO Health app on Health literacy

  3-6 months of app use

• Patient engagement with OKKO Health app

  12 months continuous use

• To explore the correlation of varying demographic and lifestyle factors on AMD disease progression

  12 months continuous use

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• OKKO Health: lead
• INNOVATEUK: collaborator
• Nottingham University Hospitals NHS Trust: collaborator
• Oxford University Hospitals NHS Trust: collaborator
• The Macular Society: collaborator

Study Sites (2)

Nottingham University Hospitals NHS Trust

Nottingham, NG7 2UH, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, OX3 9DU, United Kingdom

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Alexander Foss, D.M

  Nottingham University Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2022
• First Posted: June 27, 2022
• Study Start: March 8, 2023
• Primary Completion: April 1, 2024
• Study Completion: April 1, 2024
• Last Updated: March 10, 2023

Record last verified: 2022-12

Locations

GB (2)