Post-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population

Post-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population - An Observational Study.

Postoperative cognitive decline is a recognized complication following anesthesia and surgery in older adults; however, its incidence after ambulatory cataract surgery performed under sedation is not well understood. This prospective observational study aims to determine the proportion of patients aged 65 years and older who develop postoperative cognitive decline at 3 weeks and 3 months following ambulatory cataract surgery.

Participants will complete a baseline Tele-Montreal Cognitive Assessment (T-MoCA) before surgery and repeat the assessment remotely at 3 weeks and 3 months after surgery. Demographic, medical, anesthetic, and procedural data will also be collected. The findings will improve understanding of postoperative cognitive outcomes in elderly patients undergoing ambulatory cataract surgery and help identify patients who may be at increased risk for postoperative cognitive decline.

Study Overview

• Status: Not yet recruiting
• Conditions: Cataract Surgery Anesthesia; Post-Operative Cognitive Decline in Older Adults; Post-operative Cognitive Decline; Perioperative Neurocognitive Disorders

Detailed Description

Postoperative cognitive decline (POCD), now classified within the spectrum of perioperative neurocognitive disorders, is characterized by a decline in cognitive function following anesthesia and surgery. Although POCD has been extensively studied following major cardiac and non-cardiac procedures, limited evidence exists regarding cognitive outcomes after ambulatory procedures performed under sedation. Cataract surgery represents one of the most common surgical procedures in older adults, a population with a high prevalence of comorbidities associated with cognitive vulnerability. Despite this, postoperative cognitive outcomes following ambulatory cataract surgery remain poorly characterized.

This prospective, single-center, observational study is designed to estimate the proportion of elderly patients who develop postoperative cognitive decline following ambulatory cataract surgery performed under sedation at the Kensington Eye Institute. The study will not alter routine clinical care or anesthetic management. Participants will undergo standard perioperative care, and all anesthetic techniques, medications, and perioperative management will be determined by the treating anesthesia and surgical teams according to routine clinical practice.

Following informed consent, participants will complete a baseline cognitive assessment using the Tele-Montreal Cognitive Assessment (T-MoCA), a validated cognitive screening instrument suitable for remote administration. Demographic information, relevant medical comorbidities, home medications, and perioperative anesthetic and procedural data will also be collected. Follow-up cognitive assessments will be completed remotely using the T-MoCA at approximately 3 weeks and 3 months after surgery through secure electronic access.

The study will evaluate cognitive change by comparing follow-up T-MoCA scores with baseline performance. Postoperative cognitive decline will be defined according to a prespecified threshold based on change from baseline. In addition to estimating the incidence of postoperative cognitive decline, the study will describe the prevalence of previously unrecognized baseline cognitive impairment identified during preoperative cognitive screening.

Data will be collected using REDCap, a secure, web-based electronic data capture system. Study data will be de-identified using unique participant identification numbers, and identifiable information will be stored separately from research data in accordance with institutional privacy policies. Data quality will be maintained through standardized data collection procedures, source document verification, and routine review for completeness and accuracy.

Descriptive statistical methods will be used to estimate the proportion of participants meeting criteria for postoperative cognitive decline at each follow-up time point. The planned sample size of approximately 300 participants provides adequate precision for estimating the incidence of postoperative cognitive decline while accounting for anticipated loss to follow-up.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Naveed Siddiqui Associate Professor, MD; Phone Number: 5270 416-586-4800; Email: naveed.siddiqui@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, m5v3v2
      • Kensington Eye Institute
      • Contact: Naveed Siddiqui, MD; Phone Number: 5270 416-586-4800; Email: naveed.siddiqui@uhn.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing ambulatory cataract surgery at the Kensington Eye Institute (KEI).

Description

Inclusion Criteria:

1. All patients ages 65 and older

Exclusion Criteria:

1. Inability to understand instructions in English
2. Lack of access to a computer, tablet, smartphone, or internet access
3. Patients with established cognitive deficit diagnoses (e.g. Alzheimer's, TBI, stroke)
4. Patients with known psychiatric diagnoses
5. Patients who have undergone any procedure or surgery requiring sedation, regional, neuraxial or general anesthesia within the past 6 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Older Adults Undergoing Ambulatory Cataract Surgery; Participants aged 65 years and older undergoing ambulatory cataract surgery under sedation at the Kensington Eye Institute. This is a prospective observational cohort study in which participants will receive standard perioperative care without any study-specific intervention. Cognitive function will be assessed using the Tele-Montreal Cognitive Assessment (T-MoCA) before surgery and again at 3 weeks and 3 months after surgery to evaluate postoperative cognitive decline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery	The proportion of participants who demonstrate postoperative cognitive decline, defined as a decline of one standard deviation or greater from their baseline Tele-Montreal Cognitive Assessment (T-MoCA) score, assessed at 3 weeks and 3 months following ambulatory cataract surgery performed under sedation.	3 months post-operatively

Collaborators and Investigators

• Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Collaborators: Mount Sinai Hospital, Canada; Kensington Eye Institute
• Investigators: Principal Investigator: Naveed Siddiqui, MD, Mount Sinai Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: July 15, 2026
• First Submitted That Met QC Criteria: July 15, 2026
• First Posted (Actual): July 20, 2026

Study Record Updates

• Last Update Posted (Actual): July 20, 2026
• Last Update Submitted That Met QC Criteria: July 15, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: anesthesia; Cataract surgery; POCD; perioperative neurocognitive disorders; T-MoCa; Tele-Montreal Cognitive Assessment
• Other Study ID Numbers: 43401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No