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Enrolling by invitation

NCT Number: NCT07806487

Eye Movements to Predict Post-Operative Delirium

Postoperative delirium (POD) is a common complication in older adults undergoing surgery, lacking objective and noninvasive diagnostic methods. This trial aims to evaluate the feasibility and prognostic performance of Eye movements (EM) as a risk biomarker for the development of POD in older patients undergoing moderate- to high-risk surgery. The investigators hypothesize that EM tracking will accurately predict POD, potentially optimizing early intervention and patient outcomes.

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Clínico de la Universidad de Chile

Santiago, Santiago Metropolitan, 8320000, Chile

About this study

This prospective trial evaluates the integration of automated eye movement assessments as a novel, noninvasive risk biomarker for postoperative delirium (POD) in older adults. Upon enrollment, trained clinical staff will collect baseline demographic data and clinical characteristics. Chronic medical burden will be quantified using the Charlson Comorbidity Index (CCI). To establish baseline cognitive function and control for preexisting cognitive impairment, all participants will undergo the Montreal Cognitive Assessment (MoCA).

Technical Protocol for Eye Movement Recording

Preoperatively, participants will complete an automated eye movement tracking protocol consisting of two distinct paradigms:

Prosaccadic Task: Utilized to measure specific ocular motor parameters, including saccadic latency, velocity, and accuracy.

Free Visual Exploration Task: Utilized to capture free-gaze metrics and spatial distribution patterns.

All eye-tracking data will be recorded using automated software to ensure objectivity and reproducibility.

Postoperative Monitoring Following the surgical procedure, patients will be systematically monitored for the development of POD. The Confusion Assessment Method (CAM) will be administered by trained examiners twice daily (morning and evening) for the first three postoperative days (72 hours) to detect and document the incidence and severity of delirium.

Statistical and Predictive Objectives

The collected data will be analyzed to fulfill three primary scientific objectives:

  • Parameter Association: To identify which specific preoperative eye-tracking metrics (latency, velocity, accuracy, or free-gaze variables) demonstrate a statistically significant association with the incidence of POD.
  • Diagnostic Performance: To calculate the sensitivity and specificity of these distinct preoperative eye movement parameters for predicting POD development.
  • Incremental Predictive Value: To evaluate whether adding preoperative eye-tracking measurements to a standard clinical prediction model (comprising age, sex, CCI, and MoCA scores) significantly improves the model's overall predictive performance and risk stratification capabilities.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged 70 years or older.
  • Scheduled for moderate- to high-risk elective surgery, defined as a procedure requiring a postoperative hospital stay of at least 3 days.
  • Able to provide signed, written informed consent.

Exclusion criteria

  • Presence of delirium at baseline admission, evaluated via the Confusion Assessment Method (CAM).
  • Use of neuroleptic/antipsychotic medications within the past 6 months.
  • Prior history of dementia (including Alzheimer's disease, vascular dementia, or mild cognitive impairment).
  • History of encephalopathy.
  • Psychiatric disorders presenting with psychosis.
  • Brain injury with neurological sequelae (e.g., prior stroke, traumatic brain injury).
  • Visual acuity is insufficient to complete the automated eye-tracking tasks.
  • Illiteracy.
  • Non-Spanish speakers.
  • Concurrent participation in any other clinical trial.

Treatment and study plan

Primary outcomes

  1. Incidence of postoperative delirium (POD).

    Time frame: From the day of surgery up to postoperative day 3, patients were assessed twice daily.

    The presence or absence of postoperative delirium will be assessed using the Confusion Assessment Method (CAM). Patients will be classified as "POD" or "No POD" based on the CAM diagnostic algorithm.

Secondary outcomes

  1. Preoperative Baseline Cognitive Status

    Time frame: At preoperative baseline (day of surgery or day before).

    Total score on the Montreal Cognitive Assessment (MoCA) to determine baseline global cognitive function. The score ranges from 0 to 30, with lower scores indicating greater cognitive impairment.

  2. Preoperative Comorbidity Burden

    Time frame: At preoperative baseline (day of surgery or day before)

    Score on the Charlson Comorbidity Index (CCI) to quantify the participant's baseline medical comorbidity burden and pre-existing health conditions.

  3. Preoperative Saccadic Latency

    Time frame: At preoperative baseline (day of surgery or day before)

    The time taken from the appearance of a visual target to the initiation of the participant's saccadic eye movement during the prosaccadic task (milliseconds).

  4. Preoperative Saccadic Velocity

    Time frame: At preoperative baseline (day of surgery or day before).

    The peak speed of the participant's eye movement when moving towards the visual target during the prosaccadic task (degrees per second).

  5. Preoperative Free Viewing Number of Fixations

    Time frame: At preoperative baseline (day of surgery or day before).

    The absolute count of discrete gaze fixations made by the participant during the free visual exploration task (number of fixations)

  6. Preoperative Free Viewing Saccade Length

    Time frame: At preoperative baseline (day of surgery or day before).

    The average spatial distance between fixations in the participant's eye movements during the free visual exploration task (degrees of visual angle).

  7. Hospital Length of Stay

    Time frame: Up to 30 days post-surgery.

    Total hospital stay from the day of surgery until official hospital discharge.

  8. All-Cause Mortality

    Time frame: At 30 days post-surgery.

    Total number of participant deaths from any cause, verified via hospital electronic medical records or direct follow-up contact.

Sponsors and collaborators

Lead sponsor

University of Chile

Other

Registry information

Official study title

Predicting Post-operative Delirium Using Eye Movements: a Pilot Study

Acronym: EYE-POD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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