OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
17 de julio de 2026 actualizado por: Haotian Lin, Zhongshan Ophthalmic Center, Sun Yat-sen University
A Randomized Controlled Trial Comparing the Accuracy of the Postoperative Vision Prediction Model for Cataract Surgery (OCT-PRO) With Clinicians' Predictions of Surgical Outcomes
Cataract is the leading cause of blindness worldwide, yet 5-20% of patients fail to achieve satisfactory visual recovery after surgery.
Current methods for predicting postoperative visual acuity lack accuracy, particularly in patients with co-morbid fundus diseases.
The OCT-PRO model, developed by our team, uses artificial intelligence (AI) to integrate optical coherence tomography (OCT) images and clinical data to forecast surgical outcomes.
This multi-center, randomized, single-blind trial aims to compare the predictive accuracy of OCT-PRO-assisted predictions versus standard clinician predictions.
A total of 534 participants will be randomized 1:1 to either the experimental group (OCT-PRO-assisted prediction) or the control group (routine care).
The primary outcome is the mean absolute error (MAE) between predicted and actual postoperative best-corrected visual acuity (BCVA).
Secondary outcomes include patient satisfaction, informed decision-making scores, and clinician acceptance of the AI tool.
This study will provide high-level evidence on the clinical utility of AI in optimizing cataract surgical decision-making and patient communication.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
Cataract is the leading cause of blindness worldwide, yet 5-20% of patients fail to achieve satisfactory visual recovery after surgery. Accurate preoperative prediction remains challenging, particularly for eyes with co-morbid retinal pathologies, as current methods relying on clinician experience and traditional tests (e.g., laser interferometry) often lack reproducibility. Although AI models like OCT-PRO show promise, prospective RCT evidence comparing their accuracy against clinicians is lacking.
This multi-center, randomized, assessor-blinded trial will enroll 534 adults scheduled for cataract surgery. Participants are allocated 1:1 to either the Experimental Group or the Control Group via centralized randomization. In the Experimental Group, clinicians use the OCT-PRO model-integrating OCT images and clinical data-to obtain a predicted postoperative BCVA. Physicians may confirm or adjust this prediction, and the final value is communicated to patients during preoperative counseling. The Control Group receives standard care, where predictions are based solely on conventional clinical assessments without AI assistance. Outcome assessors will be blinded to group allocation.
The primary endpoint is the Mean Absolute Error (MAE) between predicted and actual postoperative BCVA. Secondary endpoints include patient-reported outcomes (expectations, informed choice, satisfaction), clinician acceptance of the model, and correlation analyses. Analysis will follow the Intention-to-Treat principle. This study aims to provide high-level evidence on integrating AI into clinical workflows to enhance prognostic accuracy and optimize shared decision-making in cataract surgery.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
534
Fase
- No aplica
Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Age ≥18 years scheduled to undergo phacoemulsification with intraocular lens (Phaco+IOL) implantation.
- Outpatient diagnosis of senile, complicated, or metabolic cataract.
- For bilateral cataracts, the eye with more advanced disease will be included.
Exclusion Criteria:
- History of amblyopia or neuro-ophthalmic disease in the operative eye.
- Poor-quality OCT images precluding clear visualization of fundus structures.
- Previous intraocular surgery in the operative eye.
- Hearing or intellectual impairment preventing adequate cooperation.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: OCT-PRO Assisted Prediction
Clinicians input preoperative OCT images and clinical data into the OCT-PRO model to generate a predicted postoperative BCVA.
Physicians may confirm or adjust this AI prediction to determine a final value.
This final prediction value is then communicated to the patient as supplementary information during routine preoperative counseling.
|
The OCT-PRO model integrates optical coherence tomography (OCT) images and clinical data to predict postoperative best-corrected visual acuity (BCVA).
In the experimental group, clinicians input preoperative data into the model, confirm or adjust the prediction, and communicate the final value to patients during preoperative counseling.
|
|
Comparador activo: Routine Clinical Prediction
Clinicians perform standard preoperative assessments based on clinical experience and examination results.
Predictions of postoperative visual acuity are made solely by physician judgment without AI assistance.
Patients receive routine preoperative counseling regarding surgical risks and expected outcomes.
|
Standard preoperative communication based on clinical experience and conventional examinations without AI assistance.
|
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
|---|---|
|
The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.
Periodo de tiempo: Baseline, 1 month post-surgery
|
Baseline, 1 month post-surgery
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Patient-reported consistency between surgical outcomes and expectations
Periodo de tiempo: Baseline, 1 month post-surgery
|
Patient-perceived alignment between actual surgical outcomes and preoperative expectations, measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
|
Baseline, 1 month post-surgery
|
|
Patient-reported psychological impact of preoperative prognostic disclosure
Periodo de tiempo: Baseline, 1 month post-surgery
|
Psychological response to receiving preoperative prognostic information (e.g., anxiety, reassurance), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
|
Baseline, 1 month post-surgery
|
|
Patient-reported willingness to recommend prognostic information to others
Periodo de tiempo: Baseline, 1 month post-surgery
|
Willingness to recommend cataract surgery prognostic information to others (e.g., family or friends), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
|
Baseline, 1 month post-surgery
|
|
Patient-reported satisfaction with healthcare services
Periodo de tiempo: Baseline, 1 month post-surgery
|
Patient satisfaction with overall healthcare services received during cataract surgery (e.g., communication, care quality, information clarity), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
|
Baseline, 1 month post-surgery
|
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Clinician-reported outcomes assessing the satisfaction of using OCT-PRO in cataract treatment decision-making
Periodo de tiempo: Baseline, 1 month post-surgery
|
Clinician-reported satisfaction with incorporating OCT-PRO into preoperative decision-making (e.g., ease of use, confidence in prediction, communication aid), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
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Baseline, 1 month post-surgery
|
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Correlation coefficients (Pearson/Spearman) between predicted and actual BCVA in both groups
Periodo de tiempo: From before surgery to 1 month (±1 week) post-surgery
|
From before surgery to 1 month (±1 week) post-surgery
|
Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
20 de julio de 2026
Finalización primaria (Estimado)
31 de octubre de 2026
Finalización del estudio (Estimado)
31 de diciembre de 2026
Fechas de registro del estudio
Enviado por primera vez
14 de julio de 2026
Primero enviado que cumplió con los criterios de control de calidad
17 de julio de 2026
Publicado por primera vez (Actual)
20 de julio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
20 de julio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
17 de julio de 2026
Última verificación
1 de julio de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2026KYPJ063
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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