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

24 augusti 2026 uppdaterad av: Dr. Naveed Siddiqui, Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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.

Studieöversikt

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

300

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

  • Namn: Naveed Siddiqui Associate Professor, MD
  • Telefonnummer: 5270 416-586-4800
  • E-post: naveed.siddiqui@uhn.ca

Studieorter

    • Ontario
      • Toronto, Ontario, Kanada, m5v3v2
        • Kensington Eye Institute
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Äldre vuxen

Tar emot friska volontärer

Ja

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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

Beskrivning

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, traumatic brain injury (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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery
Tidsram: 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.
3 months post-operatively

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Naveed Siddiqui, MD, Mount Sinai Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 augusti 2026

Primärt slutförande (Beräknad)

1 november 2027

Avslutad studie (Beräknad)

1 november 2027

Studieregistreringsdatum

Först inskickad

15 juli 2026

Först inskickad som uppfyllde QC-kriterierna

15 juli 2026

Första postat (Faktisk)

20 juli 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

26 augusti 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

24 augusti 2026

Senast verifierad

1 augusti 2026

Mer information

Termer relaterade till denna studie

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

NEJ

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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