Age-Related Macular DegenerationNCT05433766
Patient-centred Smartphone AI for Protecting Vision in Macular Disease
An observational study of Age-Related Macular Degeneration, run by OKKO Health at 2 sites in United Kingdom.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Age-Related Macular Degeneration
- How many people
- 500 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 8 Mar 2023to Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
Nottingham University Hospitals NHS Trust
Nottingham, NG7 2UH
Oxford University Hospitals NHS Trust
Oxford, OX3 9DU
About this study
Official title: 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.
Read the 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.
- Conditions
- Age-Related Macular Degeneration
- Medical subject headings
- Macular Degeneration
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months continuous use
Secondary outcomes (3)
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.
Measured: 3-6 months of app use
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.
Measured: 12 months continuous use
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.
Measured: 12 months continuous use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2022
- Study start8 Mar 2023
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Age-Related Macular DegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- OKKO Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- INNOVATEUK, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, The Macular Society
- Responsible party
- Sponsor
- Investigators
- Alexander Foss, D.M, Principal investigator, Nottingham University Hospitals NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05433766
- Sponsor's protocol ID
- OKHR-06
- Status last verified
- Dec 2022
- First submitted
- 16 Jun 2022
- Last updated
- 10 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Feasibility of the OKKO Health App to Monitor and Predict the Decline in Vision Caused by Age-related Macular Degeneration
- ClinicalTrials.gov ID
- NCT05433766
- Acronym / sponsor ID
- OKHR-06
- Conditions
- Age-Related Macular Degeneration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- OKKO HealthIndustry (pharma, biotech, devices)
- Collaborators
- INNOVATEUK, Nottingham University Hospitals NHS Trust, Oxford University Hospitals NHS Trust, The Macular Society
- Study start
- 8 Mar 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 27 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
- Ability to read and understand English.
- Willing and able to provide informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
Impact of the OKKO Health app on Health literacy
Time frame: 3-6 months of app use
Patient engagement with OKKO Health app
Time frame: 12 months continuous use
To explore the correlation of varying demographic and lifestyle factors on AMD disease progression
Time frame: 12 months continuous use
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Foss, D.M principal investigator
Nottingham University Hospitals NHS Trust
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Age-Related Macular Degeneration, run by OKKO Health at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in visual status (time frame: 12 months continuous use). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2023.