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Performance Evaluation of Artificial Intelligence Assisted Diabetic Retinopathy Grading in the Leuven University Hospital: Can Technology Improve the Resident?

Performance Evaluation of Artificial Intelligence Assisted Diabetic Retinopathy Grading in the Leuven University Hospital: Can Technology Improve the Resident?

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05260281
Acronym
PEARL
Enrollment
139
Registered
2022-03-02
Start date
2022-03-01
Completion date
2022-11-01
Last updated
2022-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

To Evaluate the Added Value of the Use of Artificial Intelligence in the Diagnosis of Referable Diabetic Retinopathy in a Teaching Hospital Setting

Brief summary

To evaluate the added value of the use of artificial intelligence in the diagnosis of referable diabetic retinopathy in a teaching hospital setting

Detailed description

Diabetes mellitus is one of the major health challenges of our era. It is estimated that 642 million people will be diagnosed with this disease worldwide by 2040. Diabetes is a disease effecting the entire body and comes with many possible complications due to its' effect on the microvasculature. The most prevalent of these complications is diabetic retinopathy which is caused by both microvascular and neural damage. According to studies in the United States by the Eye Diseases Prevalence Research group, about 40% of patients present with some degree of retinopathy. 8% of patients even have vision-threatening diabetic retinopathy. Diabetic retinopathy is one of the main causes of blindness in our current society. However annual screening and timely referral for treatment can prevent this from occurring. The best illustration is the fact that since the implementation of a nationwide screening program, diabetes mellitus is no longer the leading cause of blindness in the UK. Therefore, many countries have organized some sort of screening program. However, there are big organizational differences between countries. This can range from an annual dilated fundoscopy by an ophthalmologist (as is the case in Belgium) to non-mydriatic fundus photographs evaluated by a trained grader who is not a (para)medic. Even with the most efficient screening pathway possible, the increase of patient numbers will become a problem since the human factor in the screening pathway (doctor, optometrist, trained grader,…) cannot increase its' capacity with the same speed. The current system will reach its limits at one point or another. Furthermore, it is known that a significant proportion of diabetes patients do not comply with the recommended annual screening. These problems will result in longer waiting lists, underdiagnosis because of overworked doctors, long waiting lists and possibly lack of high quality care. Simply replacing the ophthalmologist by a trained grader probably won't solve all these problems. It will merely postpone them and will still remain costly and labor-intensive. The situation in countries which already use trained graders confirms these suspicions. Furthermore there is also room for improvement in the quality of care and the accuracy of diagnosis in these set ups. In recent years, artificial intelligence, more specifically deep learning, has been postulated as a means to solve these problems. Even in the first studies, deep learning algorithms have already been shown to reach high sensitivity and specificity in detecting referable diabetic retinopathy. Further development of these algorithms and more thorough research have confirmed these findings. The use of AI has been studied in many medical fields, however diabetic retinopathy screening remains the pioneer, as is confirmed by the first-ever FDA authorization for an AI medical application being the diabetic retinopathy screening system IDx. Current research mostly focusses of the performance of an artificial intelligence algorithm as an autonomous diagnostic tool without interaction with a human besides the acquisition of the images. Fear exists among medical professionals that artificial intelligence will start replacing them partially in the near future and make them obsolete on the long term. However, these novel technologies could also be used to aid the health professional in making the diagnosis in a more accurate way rather than replacing them. Therefore, in the PEARL project, we wish to evaluate the use of an artificial intelligence algorithm as a diagnostic aid to improve the diagnostic accuracy of the physician rather than replacing the physician, certainly in a training context.

Interventions

DEVICEMONA algorithm

most artificial intelligence algorithms, like the MONA algorithm used in this study, are trained on 45-degree fundus photographs. In order to incorporate the use of the algorithm, the study intervention consists of taking 1 extra 45-degree fundus photograph per eye per patient using the Zeiss Cirrus Photo 800 system.

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* \- Diagnosis of diabetes mellitus * Age \> 18 years old * Patient is capable of giving informed consent * Fluent in written and oral Dutch, or interpreter present

Exclusion criteria

* \- History of treatment for diabetic retinopathy or diabetic macular edema (laser or intravitreal injections) * Participant is contraindicated for imaging by fundus imaging systems used in the study

Design outcomes

Primary

MeasureTime frameDescription
does AI augment diagnostic performance of resident4 monthssensitivity and specificity

Secondary

MeasureTime frameDescription
does physical consultation augment diagnostic performance of AI6 monthssensitivity and specificity

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026