OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
Starting soon · Not applicable
Conditions studied: Cataract
In brief
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.
Key facts
- Study ID
- NCT07713069
- Run by
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- People needed
- 534
- Starts
- 2026-07-20
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2026-07-20
Who can join
Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.
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.
Full record on ClinicalTrials.gov
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