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AI-Assisted Interpretation of Ultra-Widefield Retinal Images

10 juni 2026 bijgewerkt door: XiujuChen, Xiamen Ophthalmology Center Affiliated to Xiamen University

Prospective Multi-Center Evaluation of AI-Assisted Interpretation of Ultra-Widefield Retinal Images in a Multi-Reader Crossover Study

The goal of this prospective observational study is to evaluate the impact of artificial intelligence (AI) assistance on clinician interpretation of ultra-widefield (UWF) retinal images.

The main questions it aims to answer are:

whether AI assistance improves the diagnostic performance of ophthalmologists in detecting retinal findings on UWF retinal images; whether AI assistance improves sensitivity, specificity, and inter-reader agreement across clinicians with different levels of experience.

Approximately 600 UWF retinal images prospectively collected from multiple ophthalmic centers in China will be included. Images will be independently annotated by expert retinal specialists to establish reference labels for retinal finding categories.

Four ophthalmologists with different levels of clinical experience, including one senior retinal specialist and three junior ophthalmologists, will participate in a crossover multi-reader study.

For each clinician, the dataset will be randomly divided into two equal subsets. During the first reading session, clinicians will evaluate one subset without AI assistance and the other subset with AI assistance. After a washout interval of at least two weeks, the reading conditions will be reversed in a second reading session with independently randomized image order.

Under the AI-assisted condition, clinicians will be provided with category-level AI prediction probabilities for retinal findings. No localization maps, heatmaps, segmentation overlays, or automated diagnostic recommendations will be displayed. Clinicians will retain full autonomy over final decisions.

Reader performance under AI-assisted and unaided conditions will be compared using expert reference annotations as the ground truth.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

This study is a prospective multi-center observational reader study designed to evaluate the impact of artificial intelligence (AI) assistance on clinician interpretation of ultra-widefield (UWF) retinal images.

Approximately 600 UWF retinal images will be prospectively collected from multiple ophthalmic centers in China. Images will be acquired using clinically routine UWF retinal imaging systems and will include a broad spectrum of retinal diseases and retinal findings encountered in real-world clinical practice.

All images will undergo independent expert annotation by retinal specialists to establish reference labels for retinal finding categories. These expert annotations will serve as the reference standard for subsequent performance evaluation.

Four ophthalmologists with different levels of clinical experience will participate in the reader study, including:

one senior retinal specialist with approximately five years of retinal clinical experience; three junior ophthalmologists with approximately two years of ophthalmology residency training.

A randomized crossover multi-reader design will be implemented to minimize recall bias and balance reading conditions.

For each clinician, the image dataset will be randomly divided into two equal subsets (subset A and subset B; approximately 300 images each).

During Round 1:

subset A will be interpreted without AI assistance; subset B will be interpreted with AI assistance.

After a washout interval of at least two weeks, the reading conditions will be reversed during Round 2:

subset A will be interpreted with AI assistance; subset B will be interpreted without AI assistance.

Image order will be independently randomized for each session and each clinician.

Under the unaided condition, clinicians will evaluate retinal images using standard clinical interpretation without AI output.

Under the AI-assisted condition, clinicians will receive category-level AI prediction probabilities for retinal finding categories. The AI output will provide probabilistic confidence scores only and will not include lesion localization maps, heatmaps, segmentation overlays, or automated binary recommendations.

Clinicians will remain blinded to the expert reference labels and to the interpretations of other readers. Final diagnostic decisions will be independently determined by each clinician.

The primary analysis will compare diagnostic performance between unaided and AI-assisted conditions, including sensitivity, specificity, area under the receiver operating characteristic curve (AUC), and inter-reader agreement.

Studietype

Observationeel

Inschrijving (Werkelijk)

462

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • China
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China
        • Chongqing Huaxia Eye Hospital
    • Fujian
      • Fuzhou, Fujian, China, 361000
        • Fuzhou Eye Hospital
      • Xiamen, Fujian, China, 361000
        • Xiamen Eye Center of Xiamen University
    • Hebei
      • Hengshui, Hebei, China
        • Hengshui Tongrui Eye Hospital
    • Shandong
      • Heze, Shandong, China
        • Heze Huaxia Eye Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Ja

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Participants undergoing clinically indicated ultra-widefield retinal imaging at participating ophthalmic centers in China, including individuals with diverse retinal diseases and retinal findings encountered in real-world clinical practice.

Beschrijving

Inclusion Criteria:

  • Participants undergoing ultra-widefield retinal imaging at participating ophthalmic centers;

Exclusion Criteria:

  • Poor-quality or ungradable retinal images;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
AI-Assisted Interpretation
Clinicians interpret ultra-widefield retinal images with access to AI-generated category-level prediction probabilities for retinal findings.
Apparaat: AI-Assisted Interpretation
Clinicians interpret ultra-widefield retinal images with access to AI-generated category-level prediction probabilities for retinal findings.
Unaided Interpretation
Clinicians interpret ultra-widefield retinal images without AI assistance using routine retinal image interpretation alone.
Apparaat: Unaided Interpretation
Clinicians interpret ultra-widefield retinal images without AI assistance using routine retinal image interpretation alone.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Sensitivity for retinal finding detection
Tijdsspanne: through study completion, an average of 2 months
Sensitivity of clinicians in detecting retinal finding categories under AI-assisted and unaided conditions using expert annotations as the reference standard.
through study completion, an average of 2 months
Specificity for retinal finding detection
Tijdsspanne: through study completion, an average of 2 months
Specificity of clinicians in detecting retinal finding categories under AI-assisted and unaided conditions.
through study completion, an average of 2 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Area under the receiver operating characteristic curve (AUC)
Tijdsspanne: through study completion, an average of 2 months
The AUC quantifies the overall ability to correctly distinguish the presence versus absence of predefined retinal findings on ultra-widefield retinal images. AUC values range from 0.5 (no discriminative ability) to 1.0 (perfect discrimination). Clinician interpretations will be compared with an expert-adjudicated reference standard under AI-assisted and unaided conditions.
through study completion, an average of 2 months
Inter-reader agreement
Tijdsspanne: At study completion (up to 3 months)
Agreement among participating clinicians in classifying predefined retinal findings on ultra-widefield retinal images. Agreement will be quantified using Cohen's kappa coefficient (for pairwise comparisons) or Fleiss' kappa coefficient (for multiple readers). Kappa values range from 0 (no agreement beyond chance) to 1 (perfect agreement).
At study completion (up to 3 months)
Diagnostic performance improvement among junior ophthalmologists
Tijdsspanne: At study completion (up to 3 months)
Improvement in diagnostic performance of junior ophthalmologists when interpreting ultra-widefield retinal images with AI assistance compared with unaided interpretation, measured by changes in sensitivity, specificity, accuracy, and AUC using the expert-adjudicated reference standard.
At study completion (up to 3 months)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Xiamen Ophthalmology Center Affiliated to Xiamen University

Onderzoekers

  • Hoofdonderzoeker: Xiuju Chen, Xiamen Eye Center of Xiamen University

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

1 januari 2026

Primaire voltooiing (Werkelijk)

1 februari 2026

Studie voltooiing (Werkelijk)

10 februari 2026

Studieregistratiedata

Eerst ingediend

5 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

10 juni 2026

Eerst geplaatst (Werkelijk)

16 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

10 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • XMYKZX-KY-2026-008

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

De-identified individual participant data underlying the results reported in this study, including retinal imaging data and associated annotations, may be made available upon reasonable request to the corresponding investigator following publication, subject to institutional ethics approval, data-sharing agreements, and applicable data governance and privacy regulations.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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