OCT-PRO Model vs. Clinicians: Cataract Surgery Outcome Prediction
A Randomized Controlled Trial Comparing the Accuracy of the Postoperative Vision Prediction Model for Cataract Surgery (OCT-PRO) With Clinicians' Predictions of Surgical Outcomes
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: OCT-PRO Assisted Prediction
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.
|
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.
|
|
Aktiv komparator: Routine Clinical Prediction
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.
|
Standard preoperative communication based on clinical experience and conventional examinations without AI assistance.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
|---|---|
|
The Mean Absolute Error (MAE) between the predicted postoperative BCVA and the actual measured BCVA at 1 month post-surgery.
Tidsram: Baseline, 1 month post-surgery
|
Baseline, 1 month post-surgery
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Patient-reported consistency between surgical outcomes and expectations
Tidsram: Baseline, 1 month post-surgery
|
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).
|
Baseline, 1 month post-surgery
|
|
Patient-reported psychological impact of preoperative prognostic disclosure
Tidsram: Baseline, 1 month post-surgery
|
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).
|
Baseline, 1 month post-surgery
|
|
Patient-reported willingness to recommend prognostic information to others
Tidsram: Baseline, 1 month post-surgery
|
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).
|
Baseline, 1 month post-surgery
|
|
Patient-reported satisfaction with healthcare services
Tidsram: Baseline, 1 month post-surgery
|
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).
|
Baseline, 1 month post-surgery
|
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Clinician-reported outcomes assessing the satisfaction of using OCT-PRO in cataract treatment decision-making
Tidsram: Baseline, 1 month post-surgery
|
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).
|
Baseline, 1 month post-surgery
|
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Correlation coefficients (Pearson/Spearman) between predicted and actual BCVA in both groups
Tidsram: From before surgery to 1 month (±1 week) post-surgery
|
From before surgery to 1 month (±1 week) post-surgery
|
Samarbetspartners och utredare
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2026KYPJ063
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