Artificial Intelligence Diagnostic Aid

NCT05675540 | Unknown DMC

• 1 other identifier: 308657
• Study Type: observational
• Target: 422
• Locations: 1 country
• Sites: 1

Brief 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). 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.

Conditions

Wet Macular Degeneration; Diabetic Macular Edema; Retinal Vein Occlusion

Outcome Measures

Primary Outcomes (1)

• 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.

  9 months

Secondary Outcomes (1)

• Anatomical and functional measures

  9 months

Interventions

Macusense Assessment Software DEVICE

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.

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Guy's and St Thomas' NHS Foundation Trust: lead

Study Sites (1)

Guy's and St Thomas's NHS Foundation Trust

London, Westminster, SE1 7EH, United Kingdom

Location

MeSH Terms

Conditions

Wet Macular Degeneration; Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Macular Degeneration; Retinal Degeneration; Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 29, 2022
• First Posted: January 9, 2023
• Study Start: June 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: March 30, 2024
• Last Updated: May 18, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)