Wet Macular DegenerationAIDNCT05675540
Artificial Intelligence Diagnostic Aid
An observational study of Wet Macular Degeneration and Diabetic Macular Edema, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
The investigators have worked with software designers to develop a software that allows us to analyse current adherence to guidelines on Ophthalmic conditions such as Age related Macular Degeneration (AMD), Diabetic Macular Edema (DMO) and Retinal vein occlusion (RVO). Read more about this study
- Who is it for?
- Ages Up to 100 years
- Conditions the study is for
- Wet Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion
- What is being tested?
- Macusense Assessment Software
- Type of treatment
- Medical device
- How many people
- 422 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2023to 30 Mar 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 Up to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Study population: Patients who attend the medical retina clinics at St Thomas' Hospital Eye Department who have a diagnosis of wet Age related Macular Degeneration, Diabetic Macular Oedema or Retinal Vein Occlusion and who have had a course of intravitreal treatment for at least 12 months. As this is a cross sectional study, some patients will have data collected only once. However some patients return to the clinic again in the time period of the trial will have subsequent data collected at each visit.
Who may be able to join
- Patients with a diagnosis of wet Age Related Macular Degeneration (wAMD), Diabetic Macular Oedema (DMO) and/or Retinal Vein Occlusion (RVO), who have already had a course of intravitreal treatment for at least one year.
Who cannot join
- Patients with more than one ophthalmic pathology will be excluded
- A patient will be excluded if, during the first year of treatment, they have needed cataract surgery or vitreoretinal surgery or have developed macular pathology other than wet AMD, DMO or RVO.
- Patients included in other trials during the period the trial is running, will be excluded from eligibility.
- Patients who do not wish to/are unable to consent will be excluded from the trial.
- Patients aged 100 years and over
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Guy's and St Thomas's NHS Foundation Trust
London, Westminster, SE1 7EH
Nigel P Davies, PhD, +442071887188 ext. 4321, nigel.davies@gstt.nhs.uk
Rosina Zakri, MB BS ChM PGDip PGCert
About this study
The investigators have worked with software designers to develop a software that allows us to analyse current adherence to guidelines on Ophthalmic conditions such as Age related Macular Degeneration (AMD), Diabetic Macular Edema (DMO) and Retinal vein occlusion (RVO). National guidelines state that those patients with fluid accumulation in their central macular, meeting criteria, are eligible for injections into the vitreous cavity of the eye (intravitreal).(1) As these condition are common the trial is relevant to the public and patients as future management may be affected by the outcomes of this trial. The investigators will trial the software which uses Artificial Intelligence (AI) algorithms to determine the most suitable review required for patients being managed in clinics, based on 'Vision' and 'Retinal Thickness' demographics. This will be done prospectively, in real time.
The question to be addressed is 'Can medical and non-medical practitioners accurately determine treatment and follow-up for patients assisted by an AI clinical decision support system, for the three most common chronic macular diseases - Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Oedema (DMO) and Retinal Vein Occlusion (RVO) - in a safe and clinically cost effective way?' Patients undergoing treatment for at least 12 months are eligible to participate, so long as they are able to provide consent for their data to be used. Participants will have no change to their care during the trial. The study, will take place at Guy's and St. Thomas' NHS FT (GSTT) from where participants will be recruited, and will last approximately 6 months of data collection.
The software will be used by the research Fellow, alongside the masked consultant. Therefore the patient pathway and management will not be impacted by this trial. Patients will be consented for data use.
Read the detailed description
Gulliksen (2017) describes digitalization as the biggest societal transformation process, including for the health-care sector. Since the challenges of the pandemic, digitalization has particularly taken place during changes to how healthcare is provided. The current Global Healthcare situation dictates flexible and innovative steps to practically adapt working methods in clinic to meet the demands of specialities, such as Ophthalmology, in safe and efficient ways. Macular disease causes devastating sight loss. It is the most common cause of preventable sight loss in the UK and the developed world, leading to unnecessary and debilitating loss of vision and blindness if not monitored and treated regularly. In the UK, 1.8M people have chronic macular disease, of which approximately 300,000 reside in London. Allied health professionals are trained to give the injections but at the moment there is no formal structure for AHPs to be trained to assess patients data (vision and OCT scan).
The investigators therefore suggest it is an important area of research, to develop a management aid to allow standardization of care, and allow more patients to be seen by increasing the clinical workforce. This new AI software enables the mobilization of the broader non-medical workforce of over 14,000 optometrists as well as nurses, allied health professionals and technicians who can be up-skilled with AI tools and training, and operate from community settings to expand resources, capacity and the quality of care. Whilst the algorithm is not aimed to improve knowledge of the diseases, there will be an element of learning of good management by the end user. There are currently many examples of automated software in literature, however they all end at the validation stage. They all address the use of AI to diagnose conditions, but none have addressed the issue of implementation, as highlighted by many of the papers. There are also no trails aimed at the management of these patients, subsequent to diagnosis.
This study will compare gold standard clinical care of patients receiving treatment for the three main macular diseases (treatment decisions made by an ophthalmologist) with an assessment and treatment recommendation made by the MacuSense software. The patients' treatment will follow the ophthalmologists decision at all times, and the result of the study will compare this with the MacuSense output. The ophthalmologist will be blind to the MacuSense output throughout the study.
The research participant will attend their clinic appointment, with measures of vision and a retinal (OCT) scan as normal. The ophthalmologist will review the patient and scan with a treatment and follow up interval decided. Treatment will be given at that visit.
The data collected will be entered into the MacuSense software by the principal investigator (Dr Zakri). The output of the software gives a follow up interval. The result of the follow up interval decided by the clinician and the follow up interval indicated by the Macusense software will be compared for each patient. The ophthalmologist will not have access to Macusense software or the output of the software, so that their treatment decision is not affected. The output of the Macusense software will not be used to change the clinical decision.
The output of the study is therefore to compare the clinician treatment and follow decision with the Macusense result, for research purposes only. The aim is to test the accuracy of the Macusense algorithm against gold standard care. The null hypothesis states that there is no difference between outcomes in standard clinical care and macusoft software.
The investigators anticipate from previous work that there is deviation from NICE guidelines on a number of occasions. Therefore The investigators suggest an alternative hypothesis that states there the outcomes will show a difference between standard care and outcomes presented from macusoft algorithm software.
Study timetable
The study is estimated to take 9 months, broadly as follows:
- Months 1-6: Research set-up, patient recruitment, data preparation. Collect data on decisions made with and without MacuSense (the algorithm will not be altered during the study)
- Months 7-9: Statistical analysis and validation of observational evidence
Study details:
How the study will operate
The study will operate as follows:
- Patient recruited and consented when attending clinic for a regular follow-up appointment.
- Consultant ophthalmologist makes a decision regarding intravitreal treatment interval following current practice.
- Patient's historical diagnostic data will be analysed by the computer program, MacuSense. This pseudonymiseddata will be able to view by Dr Zakri and the macusoft design team.
- The consultant ophthalmologists' original decision will be compared to the analysis made with MacuSense. No impact on the clinical care given will be made.
- Being tested
- Macusense Assessment Software
- Medical subject headings
- Wet Macular Degeneration, Retinal Vein Occlusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Macusense Assessment SoftwareDevice
Macusense is software designed to assess change in status and response of patients eyes undergoing intravitreal treatment for macular conditions. The output of the Macusense software will be compared with the decision of the treating clinician.
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage agreement
The primary outcome measure is the percentage of agreement between the clinical decision of follow up interval and that made by Macusense at every treatment visit for each patient.
Measured: 9 months
Secondary outcomes (1)
Anatomical and functional measures
Secondary outcome measure would include the change in central retinal thickness and macula volume as the anatomical measures and proportion of patients with loss of < 15 ETDRS letters, gain of >= 0 ETDRS letters and gain of >=15 ETDRS letters.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion30 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wet 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
- Retrospective
- Enrolment
- 422 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guy's and St Thomas' NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05675540
- Sponsor's protocol ID
- 308657
- Acronym
- AID
- Status last verified
- Dec 2022
- First submitted
- 29 Dec 2022
- Last updated
- 18 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD sharing not needed
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence Diagnostic Aid
- ClinicalTrials.gov ID
- NCT05675540
- Acronym / sponsor ID
- AID / 308657
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 422 participants (estimated)
- Lead sponsor
- Guy's and St Thomas' NHS Foundation TrustUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 30 Mar 2024 (estimated)
- First posted
- 9 Jan 2023 (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.
The investigators have worked with software designers to develop a software that allows us to analyse current adherence to guidelines on Ophthalmic conditions such as Age related Macular Degeneration (AMD), Diabetic Macular Edema (DMO) and Retinal vein occlusion (RVO). National guidelines state that those patients with fluid accumulation in their central macular, meeting criteria, are eligible for injections into the vitreous cavity of the eye (intravitreal).(1) As these condition are common the trial is relevant to the public and patients as future management may be affected by the outcomes of this trial. The investigators will trial the software which uses Artificial Intelligence (AI) algorithms to determine the most suitable review required for patients being managed in clinics, based on 'Vision' and 'Retinal Thickness' demographics. This will be done prospectively, in real time.
The question to be addressed is 'Can medical and non-medical practitioners accurately determine treatment and follow-up for patients assisted by an AI clinical decision support system, for the three most common chronic macular diseases - Wet Age-Related Macular Degeneration (wAMD), Diabetic Macular Oedema (DMO) and Retinal Vein Occlusion (RVO) - in a safe and clinically cost effective way?' Patients undergoing treatment for at least 12 months are eligible to participate, so long as they are able to provide consent for their data to be used. Participants will have no change to their care during the trial. The study, will take place at Guy's and St. Thomas' NHS FT (GSTT) from where participants will be recruited, and will last approximately 6 months of data collection.
The software will be used by the research Fellow, alongside the masked consultant. Therefore the patient pathway and management will not be impacted by this trial. Patients will be consented for data use.
Detailed description
Gulliksen (2017) describes digitalization as the biggest societal transformation process, including for the health-care sector. Since the challenges of the pandemic, digitalization has particularly taken place during changes to how healthcare is provided. The current Global Healthcare situation dictates flexible and innovative steps to practically adapt working methods in clinic to meet the demands of specialities, such as Ophthalmology, in safe and efficient ways. Macular disease causes devastating sight loss. It is the most common cause of preventable sight loss in the UK and the developed world, leading to unnecessary and debilitating loss of vision and blindness if not monitored and treated regularly. In the UK, 1.8M people have chronic macular disease, of which approximately 300,000 reside in London. Allied health professionals are trained to give the injections but at the moment there is no formal structure for AHPs to be trained to assess patients data (vision and OCT scan).
The investigators therefore suggest it is an important area of research, to develop a management aid to allow standardization of care, and allow more patients to be seen by increasing the clinical workforce. This new AI software enables the mobilization of the broader non-medical workforce of over 14,000 optometrists as well as nurses, allied health professionals and technicians who can be up-skilled with AI tools and training, and operate from community settings to expand resources, capacity and the quality of care. Whilst the algorithm is not aimed to improve knowledge of the diseases, there will be an element of learning of good management by the end user. There are currently many examples of automated software in literature, however they all end at the validation stage. They all address the use of AI to diagnose conditions, but none have addressed the issue of implementation, as highlighted by many of the papers. There are also no trails aimed at the management of these patients, subsequent to diagnosis.
This study will compare gold standard clinical care of patients receiving treatment for the three main macular diseases (treatment decisions made by an ophthalmologist) with an assessment and treatment recommendation made by the MacuSense software. The patients' treatment will follow the ophthalmologists decision at all times, and the result of the study will compare this with the MacuSense output. The ophthalmologist will be blind to the MacuSense output throughout the study.
The research participant will attend their clinic appointment, with measures of vision and a retinal (OCT) scan as normal. The ophthalmologist will review the patient and scan with a treatment and follow up interval decided. Treatment will be given at that visit.
The data collected will be entered into the MacuSense software by the principal investigator (Dr Zakri). The output of the software gives a follow up interval. The result of the follow up interval decided by the clinician and the follow up interval indicated by the Macusense software will be compared for each patient. The ophthalmologist will not have access to Macusense software or the output of the software, so that their treatment decision is not affected. The output of the Macusense software will not be used to change the clinical decision.
The output of the study is therefore to compare the clinician treatment and follow decision with the Macusense result, for research purposes only. The aim is to test the accuracy of the Macusense algorithm against gold standard care. The null hypothesis states that there is no difference between outcomes in standard clinical care and macusoft software.
The investigators anticipate from previous work that there is deviation from NICE guidelines on a number of occasions. Therefore The investigators suggest an alternative hypothesis that states there the outcomes will show a difference between standard care and outcomes presented from macusoft algorithm software.
Study timetable
The study is estimated to take 9 months, broadly as follows:
- Months 1-6: Research set-up, patient recruitment, data preparation. Collect data on decisions made with and without MacuSense (the algorithm will not be altered during the study)
- Months 7-9: Statistical analysis and validation of observational evidence
Study details:
How the study will operate
The study will operate as follows:
- Patient recruited and consented when attending clinic for a regular follow-up appointment.
- Consultant ophthalmologist makes a decision regarding intravitreal treatment interval following current practice.
- Patient's historical diagnostic data will be analysed by the computer program, MacuSense. This pseudonymiseddata will be able to view by Dr Zakri and the macusoft design team.
- The consultant ophthalmologists' original decision will be compared to the analysis made with MacuSense. No impact on the clinical care given will be made.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- Up to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Study population: Patients who attend the medical retina clinics at St Thomas' Hospital Eye Department who have a diagnosis of wet Age related Macular Degeneration, Diabetic Macular Oedema or Retinal Vein Occlusion and who have had a course of intravitreal treatment for at least 12 months. As this is a cross sectional study, some patients will have data collected only once. However some patients return to the clinic again in the time period of the trial will have subsequent data collected at each visit.
Key inclusion criteria (1 listed)
- Patients with a diagnosis of wet Age Related Macular Degeneration (wAMD), Diabetic Macular Oedema (DMO) and/or Retinal Vein Occlusion (RVO), who have already had a course of intravitreal treatment for at least one year.
Key exclusion criteria (5 listed)
- Patients with more than one ophthalmic pathology will be excluded
- A patient will be excluded if, during the first year of treatment, they have needed cataract surgery or vitreoretinal surgery or have developed macular pathology other than wet AMD, DMO or RVO.
- Patients included in other trials during the period the trial is running, will be excluded from eligibility.
- Patients who do not wish to/are unable to consent will be excluded from the trial.
- Patients aged 100 years and over
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Macusense Assessment SoftwareMacusense is software designed to assess change in status and response of patients eyes undergoing intravitreal treatment for macular conditions. The output of the Macusense software will be compared with the decision of the treating clinician. | Device | – |
Primary outcome
Percentage agreement
Time frame: 9 months
The primary outcome measure is the percentage of agreement between the clinical decision of follow up interval and that made by Macusense at every treatment visit for each patient.
1 secondary outcome
Anatomical and functional measures
Time frame: 9 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
- Individual participant dataSharing planned: No. IPD sharing not needed
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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.
Guy's and St Thomas's NHS Foundation Trust
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Wet Macular Degeneration and Diabetic Macular Edema, run by Guy's and St Thomas' NHS Foundation Trust at 1 site 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 1 inclusion and 5 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 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage agreement (time frame: 9 months). 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 18 May 2023.