- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07714174
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.
Przegląd badań
Status
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Naveed Siddiqui Associate Professor, MD
- Numer telefonu: 5270 416-586-4800
- E-mail: naveed.siddiqui@uhn.ca
Lokalizacje studiów
-
-
Ontario
-
Toronto, Ontario, Kanada, m5v3v2
- Kensington Eye Institute
-
Kontakt:
- Naveed Siddiqui, MD
- Numer telefonu: 5270 416-586-4800
- E-mail: naveed.siddiqui@uhn.ca
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Starszy dorosły
Akceptuje zdrowych ochotników
Metoda próbkowania
Badana populacja
Opis
Inclusion Criteria:
1. All patients ages 65 and older
Exclusion Criteria:
- 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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
Kohorty i interwencje
Grupa / Kohorta |
|---|
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery
Ramy czasowe: 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
|
Współpracownicy i badacze
Śledczy
- Główny śledczy: Naveed Siddiqui, MD, Mount Sinai Hospital
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- 43401
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .
Badania kliniczne na Znieczulenie do operacji zaćmy
-
RxSight, Inc.Rejestracja na zaproszenie
-
Adaptilens, Inc.Jeszcze nie rekrutacjaAphakia Cataract
-
University Hospital TuebingenRobert Bosch-Krankenhaus StuttgartRekrutacyjny