AI vs. human eye: study tests if smart software improves retinal reports
NCT ID NCT07291960
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at whether giving eye doctors AI-generated measurements from retinal images helps them write more accurate and complete reports. About 29 ophthalmologists and trainees will be randomly assigned to use AI tools or just the original images. A panel of senior experts will then judge the quality of the reports without knowing which group wrote them. The goal is to see if AI assistance improves report quality and saves time.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 29 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Apr 2026
An estimate. Start dates often move.
- Expected to finish
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May 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
The study population consists of practicing ophthalmologists and ophthalmology trainees who are responsible for interpreting fundus images and generating clinical reports. These clinicians will be randomly assigned to either the intervention group, which has access to AI-derived quantitative retinal information during report writing, or the control group, which performs report writing using only the original fundus images without AI assistance. A separate panel of senior ophthalmologists, who are not involved in the reporting task, will serve as blinded expert evaluators. They will independently assess all completed reports based on predefined quality dimensions, including accuracy, completeness, clarity, and consistency of interpretation. The retinal fundus images used in this study are de-identified clinical images representing a range of normal and abnormal retinal presentations. All images are of sufficient quality for interpretation and contain no patient-identifiable information
- Ages
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Clinician Participants (Report Writers) 1. Board-certified ophthalmologists or ophthalmology trainees (registrars or fellows) with clinical experience in interpreting fundus images. 2. Capable of independently completing retinal clinical reports based on fundus photography. 3. Willing and able to participate in the study tasks (report writing) under assigned study conditions. 4. Able to provide informed consent. Expert Evaluators (Outcome Assessors) 1. Senior ophthalmologists with at least 5 years of post-certification clinical experience. 2. Not involved in the report-writing stage of the study. 3. Willing to evaluate de-identified reports across predefined quality dimensions. 4. Able to provide informed consent. Fundus Images (Data Inputs) 1. Retinal fundus photographs of sufficient quality for clinical interpretation. 2. Images representing a range of common retinal findings (normal or abnormal). 3. Previously collected, de-identified images with no patient-identifiable information. Exclusion Criteria: Clinician Participants 1. Lack of experience in interpreting fundus images (e.g., interns, medical students). 2. Prior involvement in the development, training, or validation of the AI system being tested. 3. Inability to complete reporting tasks due to time constraints or technical limitations. 4. Any condition that may interfere with ability to perform study tasks (e.g., prolonged absence). Expert Evaluators 1. Participation in the intervention or control reporting arms. 2. Prior exposure to or involvement in development of the AI system. 3. Any conflict of interest affecting impartiality of report quality evaluation. Fundus Images 1. Poor-quality images with insufficient clarity for interpretation. 2. Images containing artifacts or cropping that prevent accurate segmentation or assessment. 3. Images with any remaining patient identifiers (excluded to maintain confidentiality).
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
The full official record for this study. This one lists no contact details, but it is the first place any would appear.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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