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NCT Number: NCT07291960

Retinal Clinical Assessment With AI-derived Quantitative Information

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Clinician Participants (Report Writers)

  • 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.

Expert Evaluators (Outcome Assessors)

  • Senior ophthalmologists with at least 5 years of post-certification clinical experience.
  • Not involved in the report-writing stage of the study.
  • Willing to evaluate de-identified reports across predefined quality dimensions.
  • Able to provide informed consent.

Fundus Images (Data Inputs)

  • Retinal fundus photographs of sufficient quality for clinical interpretation.
  • Images representing a range of common retinal findings (normal or abnormal).
  • Previously collected, de-identified images with no patient-identifiable information.

Exclusion criteria

Clinician Participants

  • 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).

Expert Evaluators

  • Participation in the intervention or control reporting arms.
  • Prior exposure to or involvement in development of the AI system.
  • Any conflict of interest affecting impartiality of report quality evaluation.

Fundus Images

  • Poor-quality images with insufficient clarity for interpretation.
  • Images containing artifacts or cropping that prevent accurate segmentation or assessment.
  • Images with any remaining patient identifiers (excluded to maintain confidentiality).

Treatment and study plan

AI-derived retinal quantitative information-assisted reporting

Diagnostic Test

Clinicians assigned to the intervention arm will complete retinal clinical reports with access to an AI system that provides automated retinal feature quantification. The system generates multiple quantitative retinal biomarkers-including vessel characteristics, optic nerve head metrics, macular indices, and other region-specific structural measurements-derived from automated segmentation of each fundus image.

During report writing, clinicians can view these AI-generated quantitative values alongside the image. The system does not provide diagnostic labels, impressions, or textual interpretations; it only supplies numerical measurements intended to support clinicians' assessment. All clinical judgments, narrative descriptions, and final conclusions in the report are made solely by the clinician.

Primary outcomes

  1. Expert-rated clinical report quality

    Time frame: Assessed after completion of all reporting tasks (approximately 1-2 weeks per participant)

    All clinical reports generated by clinicians in both the AI-assisted and control groups will be anonymized and independently evaluated by a separate panel of senior ophthalmologists who are blinded to group allocation. The expert evaluators will score each report using predefined criteria assessing accuracy, completeness, clarity, consistency with the fundus image, and overall clinical quality. Scores will be recorded using a standardized multi-dimensional rating scale. The primary outcome is the mean overall quality score per report.

Sponsors and collaborators

Lead sponsor

Beijing Tongren Hospital

Other

Registry information

Official study title

AI-derived Retinal Quantification Versus Routine Clinical Interpretation in Ophthalmic Assessment: a Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Dec 18, 2025
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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