NCT07713069 OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
| NCT ID | NCT07713069 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Zhongshan Ophthalmic Center, Sun Yat-sen University |
| Condition | Cataract |
| Study Type | INTERVENTIONAL |
| Enrollment | 534 participants |
| Start Date | 2026-07-21 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 534 participants in total. It began in 2026-07-21 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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.
Frequently Asked Questions
Who can join the NCT07713069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Cataract. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07713069 currently recruiting?
Yes, NCT07713069 is actively recruiting participants. Visit ClinicalTrials.gov or contact Zhongshan Ophthalmic Center, Sun Yat-sen University to inquire about joining.
Where is the NCT07713069 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07713069 clinical trial?
NCT07713069 is sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. The trial plans to enroll 534 participants.