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NCT07713069
OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
Conditions: Cataract
Sex: All
Ages: 18 Years – 90 Years
Healthy volunteers: No
Phase: NA
Enrollment: 534
Sponsor: Zhongshan Ophthalmic Center, Sun Yat-sen University
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07713069). StuddyBuddy aggregates publicly available trial information.