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Not Yet Recruiting NCT05675540

Artificial Intelligence Diagnostic Aid

Conditions: Wet Macular Degeneration, Diabetic Macular Edema, Retinal Vein Occlusion

Sex: All
Ages: N/A – 100 Years
Enrollment: 422
Sponsor: Guy's and St Thomas' NHS Foundation Trust

Location: United Kingdom

Summary

We 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. We 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.

Eligibility Criteria

Inclusion Criteria: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.Exclusion Criteria:Patients with more than one ophthalmic pathology will be excludedA 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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05675540). StuddyBuddy aggregates publicly available trial information.