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NCT05675540: AID

Artificial Intelligence Diagnostic Aid

Status unknown Last updated 18 May 2023
What this trial tests

trial testing Macusense Assessment Software in Wet Macular Degeneration in 422 participants. Status unknown.

Timeline
1 June 2023
Primary endpoint
1 December 2023
30 March 2024

Quick facts

Lead sponsorGuy's and St Thomas' NHS Foundation Trust
StatusStatus unknown
Study typeOBSERVATIONAL
Enrollment422
Start date1 June 2023
Primary completion1 December 2023
Estimated completion30 March 2024
Sites1 location across United Kingdom

Drugs / interventions tested

Conditions studied

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Who can join

Under 100, any sex, with Wet Macular Degeneration or Diabetic Macular Edema. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Artificial intelligence for diagnosing exudative age-related macular degeneration.
    Kang C, Lo JE, Zhang H, Ng SM, et al · · 2024 · cited 9× · PMID 39417312 · DOI 10.1002/14651858.cd015522.pub2

Verify or expand the search:

Other recruiting trials for Wet Macular Degeneration

Currently open trials in the same condition.

Other Guy's and St Thomas' NHS Foundation Trust trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05675540.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing