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AI vs. human eye: study tests if smart software improves retinal reports

NCT ID NCT07291960

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Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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Status unknown
This status has not been confirmed recently, so it may be out of date.

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

About 29 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

May 2026

An estimate. End dates often move.

Lead sponsor

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

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show 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

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How to take part

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  1. The official record

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