Retinal Clinical Assessment With AI-derived Quantitative Information

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorBeijing Tongren Hospital

About this trial

This randomized controlled trial evaluates whether providing clinicians with AI-derived quantitative retinal information improves the quality and efficiency of retinal clinical assessment. Participating ophthalmologists and ophthalmology trainees will be randomly assigned to one of two groups. The intervention group will write clinical reports with access to automated quantitative measurements generated from fundus image analysis, including multiple retinal structural and vascular biomarkers. The control group will complete the same reporting tasks using only the original fundus images without AI-generated quantitative information.

All reports produced by both groups will be de-identified and independently evaluated by a separate panel of senior ophthalmologists who are blinded to group allocation. The expert evaluators will assess report accuracy, completeness, clarity, and overall clinical quality using predefined scoring criteria. The study aims to determine whether access to quantitative retinal biomarkers enhances clinicians' reporting performance and reduces reporting time during retinal assessment tasks.

Eligibility criteria

Qualifiers

Board-certified ophthalmologists or ophthalmology trainees (registrars or fellows) with clinical experience in interpreting fundus images.

Capable of independently completing retinal clinical reports based on fundus photography.

Willing and able to participate in the study tasks (report writing) under assigned study conditions.

Able to provide informed consent.

Disqualifiers

Lack of experience in interpreting fundus images (e.g., interns, medical students).

Prior involvement in the development, training, or validation of the AI system being tested.

Inability to complete reporting tasks due to time constraints or technical limitations.

Any condition that may interfere with ability to perform study tasks (e.g., prolonged absence).

Trial design

Treatments tested in this trial

  • AI-derived retinal quantitative information-assisted reporting

Treatment groups

29 Participants
are divided into 3 treatment groups

Locations

This trial has no locations

Sponsors and collaborators