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NOT YET RECRUITING
NCT07713069
NA

OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction

Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

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.

Official title: A Randomized Controlled Trial Comparing the Accuracy of the Postoperative Vision Prediction Model for Cataract Surgery (OCT-PRO) With Clinicians' Predictions of Surgical Outcomes

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

534

Start Date

2026-07-20

Completion Date

2026-12-31

Last Updated

2026-07-20

Healthy Volunteers

No

Conditions

Interventions

DEVICE

OCT-PRO prediction model

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.

BEHAVIORAL

Routine Preoperative Counseling

Standard preoperative communication based on clinical experience and conventional examinations without AI assistance.