Post-Operative Cognitive Decline in Older AdultsNCT07714174
Post-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population
An observational study of Post-Operative Cognitive Decline in Older Adults and Post-operative Cognitive Decline, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post-Operative Cognitive Decline in Older Adults, Post-operative Cognitive Decline, Perioperative Neurocognitive Disorders
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Aug 2026to 1 Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: Patients undergoing ambulatory cataract surgery at the Kensington Eye Institute (KEI).
Who may be able to join
- 1. All patients ages 65 and older
Who cannot join
- 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, traumatic brain injury (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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
Kensington Eye Institute
Toronto, Ontario, m5v3v2
Naveed Siddiqui, MD, 416-586-4800 ext. 5270, naveed.siddiqui@uhn.ca
About this study
Official title: 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.
Read the 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 Research Electronic Data Capture (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.
- Conditions
- Post-Operative Cognitive Decline in Older Adults, Post-operative Cognitive Decline, Perioperative Neurocognitive Disorders, Cataract Surgery Anesthesia
- Keywords
- perioperative neurocognitive disorders, POCD, T-MoCa, Tele-Montreal Cognitive Assessment, Cataract surgery, anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Nov 2027 (estimated)
- Study completion1 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative Cognitive Decline in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Kensington Eye Institute
- Responsible party
- Principal investigator, Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital
- Investigators
- Naveed Siddiqui, MD, Principal investigator, MOUNT SINAI HOSPITAL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07714174
- Sponsor's protocol ID
- 43401
- Status last verified
- Aug 2026
- First submitted
- 15 Jul 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Cognitive Decline After Ambulatory Cataract Surgery in the Elderly Population - An Observational Study
- ClinicalTrials.gov ID
- NCT07714174
- Acronym / sponsor ID
- 43401
- Conditions
- Post-Operative Cognitive Decline in Older Adults, Post-operative Cognitive Decline, Perioperative Neurocognitive Disorders, Cataract Surgery Anesthesia
- Keywords
- perioperative neurocognitive disorders, POCD, T-MoCa, Tele-Montreal Cognitive Assessment, Cataract surgery, anesthesia
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Samuel Lunenfeld Research Institute, Mount Sinai HospitalUniversity, hospital or other
- Collaborators
- Mount Sinai Hospital, Canada, Kensington Eye Institute
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Nov 2027 (estimated)
- Study completion
- 1 Nov 2027 (estimated)
- First posted
- 20 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 Research Electronic Data Capture (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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- Patients undergoing ambulatory cataract surgery at the Kensington Eye Institute (KEI).
Key inclusion criteria (1 listed)
- 1. All patients ages 65 and older
Key exclusion criteria (5 listed)
- 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, traumatic brain injury (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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery
Time frame: 3 months post-operatively
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Post-Operative Cognitive Decline in Older Adults
Active, not recruitingObservational study
Association of POCD With Circulating Biomarkers in Patients Undergoing TUR of Bladder Tumor
Cognitive Decline, Urinary Bladder Cancer
Enrolling by invitationPhase 4
Effects of Ciprofol on Perioperative Neurocognitive Function in Elderly Patients Undergoing Daytime Surgery
PND, POCD - Postoperative Cognitive Dysfunction
Not yet recruitingObservational study
Postsurgical Pain and Opioid Use in Older Adults: Effects of Mild Cognitive Impairment
Mild Cognitive Impairment (MCI), Opioid Use
Not yet recruitingObservational study
PCO₂ Gap and Lactate as Predictors of POCD After Cardiac Surgery
Postoperative Cognitive Dysfunction (POCD), Cardiac Surgery
RecruitingObservational study
Cognitive Dysfunction and Delirium After TUR-M in Elderly Patients
Postoperative Delirium, Postoperative Cognitive Dysfunction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Naveed Siddiqui, MD principal investigator
MOUNT SINAI HOSPITAL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post-Operative Cognitive Decline in Older Adults and Post-operative Cognitive Decline, run by Samuel Lunenfeld Research Institute, Mount Sinai Hospital at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Naveed Siddiqui Associate Professor, MD (416-586-4800 ext. 5270, naveed.siddiqui@uhn.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery (time frame: 3 months post-operatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.