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

NCT07713069 | Not Yet Recruiting DMC

• 1 other identifier: 2026KYPJ063
• Study Type: interventional
• Target: 534
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Cataract

Keywords

Cataract; Post-operative prognosis; Artificial intelligence; Multimodal data fusion; Clinical decision support

Outcome Measures

Primary Outcomes (1)

• The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.

  Baseline, 1 month post-surgery

Secondary Outcomes (6)

• Patient-reported consistency between surgical outcomes and expectations

  Baseline, 1 month post-surgery

• Patient-reported psychological impact of preoperative prognostic disclosure

  Baseline, 1 month post-surgery

• Patient-reported willingness to recommend prognostic information to others

  Baseline, 1 month post-surgery

• Patient-reported satisfaction with healthcare services

  Baseline, 1 month post-surgery

• Clinician-reported outcomes assessing the satisfaction of using OCT-PRO in cataract treatment decision-making

  Baseline, 1 month post-surgery

Study Arms (2)

OCT-PRO Assisted Prediction

EXPERIMENTAL

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.

Device: OCT-PRO prediction model

Routine Clinical Prediction

ACTIVE COMPARATOR

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.

Behavioral: Routine Preoperative Counseling

Interventions

Routine Preoperative Counseling BEHAVIORAL

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

Routine Clinical Prediction

OCT-PRO prediction model DEVICE

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.

OCT-PRO Assisted Prediction

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zhongshan Ophthalmic Center, Sun Yat-sen University: lead

MeSH Terms

Conditions

Cataract

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 20, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share