An observational study in no Obvious Abnormalities, Diabetic Retinopathy (DR) and AMD, sponsored by Beijing Tongren Hospital. Not yet recruiting. Per ClinicalTrials.gov, last updated 2026-04-29.
Sponsored by Beijing Tongren Hospital · Observational
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.
778 studies on the registry are indexed under Diabetic Retinopathy; 142 are open to participants now.
This study's planned enrollment of 29 is below the median of 172 across 263 observational studies indexed under Diabetic Retinopathy.
Browse Diabetic Retinopathy studies →Beijing Tongren Hospital is the lead sponsor of 164 studies on the registry; 54 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Clinician Participants (Report Writers)
Expert Evaluators (Outcome Assessors)
Fundus Images (Data Inputs)
Exclusion Criteria:
Clinician Participants
Expert Evaluators
Fundus Images
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Diagnostic Test: AI-derived retinal quantitative information-assisted reporting
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.
Expert-rated clinical report quality
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.
Time frame: Assessed after completion of all reporting tasks (approximately 1-2 weeks per participant)
No study locations are listed for this record.
Start is estimated for Apr 2026; primary completion for May 2026, 1 month later.
Of 73 non-industry observational studies under Diabetic Retinopathy, half reached primary completion within 32 months of starting (the median), counting those still running; a quarter within 14. This study's planned 1 month is below that.
Counting every sponsor, half of 90 studies reached it within 28 months; a quarter within 13 and three quarters within 61.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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