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临床试验/NCT07714174
NCT07714174尚未招募不适用

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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2026年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
300
试验地点
1
主要终点
Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • 1. All patients ages 65 and older

排除标准

  • 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

结局指标

主要结局

Proportion of patients with postoperative cognitive decline following sedation for ambulatory cataract surgery

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Naveed Siddiqui

Principal Investigator

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

研究点 (1)

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