An interventional study of OCT-PRO prediction model and Routine Preoperative Counseling in Cataract, sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University. Recruiting at 1 site in China. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Zhongshan Ophthalmic Center, Sun Yat-sen University · Not applicable, Interventional, and Other
Among 19 studies in Cataract by Zhongshan Ophthalmic Center, Sun Yat-sen University — 10 open to participants now, 10 under way, none of them phase 3. Cataract · Zhongshan Ophthalmic Center, Sun Yat-sen University.
Among the 19 studies in Cataract by Zhongshan Ophthalmic Center, Sun Yat-sen University, this one has the largest planned enrollment of the 13 interventional ones that give a count, is one of 4 that started in 2026, is one of 13 with no phase, and was the 19th registered.
1,630 studies on the registry are indexed under Cataract; 235 are open to participants now.
Browse Cataract studies →10 of the 19 studies in Cataract by Zhongshan Ophthalmic Center, Sun Yat-sen University are open now, in 1 country. Recruiting first, the newest first:
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 50–90
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18+
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 18+ · Healthy volunteers
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 50–80
Zhongshan Ophthalmic Center, Sun Yat-sen University · Sites in China
Ages 65+ · Healthy volunteers
By country, each count listing its studies:
Of the 142 Cataract studies recruiting now, 88 (62%) set no upper age limit and 8 (6%) stop at 75 or younger; 10 take children under 18; 16 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
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19 studies; the count open now beside each. This study's row is marked.
First in 2017; this study’s year is marked. 4 started in 2026.
This study's planned enrollment of 534 is above the median of 79 across 1,093 interventional studies indexed under Cataract.
Median enrollment 128 across the 13 interventional studies, 2,927 across the 6 observational. Of the 5 that completed or were terminated, 0 (0%) have results posted.
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Zhongshan Ophthalmic Center, Sun Yat-sen University is the lead sponsor of 164 studies on the registry; 80 are open to participants now.
3 of the studies in Cataract by Zhongshan Ophthalmic Center, Sun Yat-sen University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07713069Zhongshan Ophthalmic Center, Sun Yat-sen UniversityOCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction | 2026-11-30 |
| NCT07550907Zhongshan Ophthalmic Center, Sun Yat-sen UniversityThe Impact of Surgical Procedures on Postoperative Outcomes in Cataract Phacoemulsification and Analysis of Related Factors | 2026-12-31 |
| NCT07126470Zhongshan Ophthalmic Center, Sun Yat-sen UniversityImpact of Capsular Tension Ring on Intraocular Lens Position in Retinitis Pigmentosa Cataract Patients | 2027-08 |
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Among the 19 studies in Cataract by Zhongshan Ophthalmic Center, Sun Yat-sen University, from their registry updates:
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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.
Cataract is the leading cause of blindness worldwide, yet 5-20% of patients fail to achieve satisfactory visual recovery after surgery. Accurate preoperative prediction remains challenging, particularly for eyes with co-morbid retinal pathologies, as current methods relying on clinician experience and traditional tests (e.g., laser interferometry) often lack reproducibility. Although AI models like OCT-PRO show promise, prospective RCT evidence comparing their accuracy against clinicians is lacking.
This multi-center, randomized, assessor-blinded trial will enroll 534 adults scheduled for cataract surgery. Participants are allocated 1:1 to either the Experimental Group or the Control Group via centralized randomization. In the Experimental Group, clinicians use the OCT-PRO model-integrating OCT images and clinical data-to obtain a predicted postoperative BCVA. Physicians may confirm or adjust this prediction, and the final value is communicated to patients during preoperative counseling. The Control Group receives standard care, where predictions are based solely on conventional clinical assessments without AI assistance. Outcome assessors will be blinded to group allocation.
The primary endpoint is the Mean Absolute Error (MAE) between predicted and actual postoperative BCVA. Secondary endpoints include patient-reported outcomes (expectations, informed choice, satisfaction), clinician acceptance of the model, and correlation analyses. Analysis will follow the Intention-to-Treat principle. This study aims to provide high-level evidence on integrating AI into clinical workflows to enhance prognostic accuracy and optimize shared decision-making in cataract surgery.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
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.
Standard preoperative communication based on clinical experience and conventional examinations without AI assistance.
The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.
Time frame: Baseline, 1 month post-surgery
Patient-reported consistency between surgical outcomes and expectations
Patient-perceived alignment between actual surgical outcomes and preoperative expectations, measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
Time frame: Baseline, 1 month post-surgery
Patient-reported psychological impact of preoperative prognostic disclosure
Psychological response to receiving preoperative prognostic information (e.g., anxiety, reassurance), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
Time frame: Baseline, 1 month post-surgery
Patient-reported willingness to recommend prognostic information to others
Willingness to recommend cataract surgery prognostic information to others (e.g., family or friends), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
Time frame: Baseline, 1 month post-surgery
Patient-reported satisfaction with healthcare services
Patient satisfaction with overall healthcare services received during cataract surgery (e.g., communication, care quality, information clarity), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
Time frame: Baseline, 1 month post-surgery
Clinician-reported outcomes assessing the satisfaction of using OCT-PRO in cataract treatment decision-making
Clinician-reported satisfaction with incorporating OCT-PRO into preoperative decision-making (e.g., ease of use, confidence in prediction, communication aid), measured via a validated questionnaire using a 5-point Likert scale (strongly disagree to strongly agree).
Time frame: Baseline, 1 month post-surgery
Correlation coefficients (Pearson/Spearman) between predicted and actual BCVA in both groups
Time frame: From before surgery to 1 month (±1 week) post-surgery
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Nov 2026, 4 months after the start.
Of 302 non-industry interventional studies with no phase under Cataract, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 30. This study's planned 4 months is below that.
Counting every sponsor, half of 492 studies reached it within 17 months; a quarter within 9 and three quarters within 28.
Primary completion moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Nov 12, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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