NCT07714174

Brief Summary

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
15mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 15, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 20, 2026

Completed
12 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2027

Last Updated

July 20, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 15, 2026

Last Update Submit

July 15, 2026

Conditions

Keywords

perioperative neurocognitive disordersPOCDT-MoCaTele-Montreal Cognitive AssessmentCataract surgeryanesthesia

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \. All patients ages 65 and older

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kensington Eye Institute

Toronto, Ontario, m5v3v2, Canada

Location

Study Officials

  • Naveed Siddiqui, MD

    MOUNT SINAI HOSPITAL

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Naveed Siddiqui Associate Professor, MD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 15, 2026

First Posted

July 20, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

November 1, 2027

Study Completion (Estimated)

November 1, 2027

Last Updated

July 20, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations