Patient-centred Smartphone AI for Protecting Vision in Macular Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-03-08

Study Completion Date

2024-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT05569226

Age-Related Macular Degeneration

UNKNOWN

Optimising Visual Acuity Measurement in Macular Degeneration

NCT04920071

Age Related Macular Degeneration

COMPLETED

Research of Automated Maculopathy Screening Based on AI Techniques Using OCT Images

NCT03476291

Maculopathy

UNKNOWN

Artificial Intelligence Diagnostic Aid

NCT05675540

Wet Macular Degeneration Diabetic Macular Edema Retinal Vein Occlusion

UNKNOWN

Personalized Shared Eye-care Identification of Age-related Macular Degeneration Using Artificial Intelligence and Telemedicine by Matching Optometrist Office-based Sites With Clinical Supervision

NCT06465212

Age-Related Macular Degeneration

NOT_YET_RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Age-Related Macular Degeneration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No