Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Correlation between visual acuity and cognitive function at 3 months after Cataract Surgery.
研究概览
简要总结
The study intends to measure the evolution over time of the cognitive capacity of patients undergoing cataract surgery in relation to the opaque lens removal surgery (cataract) in a population considered to be at risk of neurocognitive degeneration.
Secondary objectives:
• Estimate the incidence of postoperative cognitive dysfunctions and any episodes of perioperative delirium with the aim of demonstrating the safety of cataract surgery in the elderly patient in terms of cognitive functions and impact on the psychological state.
In the context of the study a risk sub-population analysis will be carried out, evaluating the trend over time of the "endothelial cells count" parameter
The elderly population remains, due to the aging of the cornea, a population "at risk" for significant alterations from the clinical point of view. During the study the endothelial cells count will be monitored, in order to be able to evaluate the safety of the cataract surgery and to be able to correctly correlate a possible deterioration in the visual acuity of patients with corneal decompensation. To evaluate the progress of the endothelial cells count in the elderly patient during the pre-intervention and post-intervention period. Since the low values of cellular media in endothelial microscopy are an element that increases the risk of complications during cataract surgery, the study wants to assess how waiting times between filter visits and cataract surgery can cause an elderly patient worsening of this parameter even in a few months. The trend of the same parameter will be monitored even after the intervention since in case of decrease, the low endothelial count could cause an alteration of visual acuity and therefore a minor improvement in cognitive performance.
The research will be set as a longitudinal observational study where will be compared in each patient the parameters analyzed in the 6 months prior to cataract surgery and in the 3 months following the operation itself. Patients will be enrolled during the first cataract filter visit, will be submitted to simple questions and their clinical data will be collected. Subsequently, before and after three months of surgery repeated cognitive testing and the control normally performed instrumental tests during follow-up.
A clinical follow-up will be provided, during normal follow-up visits at 20 days and 6 months after the patient's surgery: the following information will be collected during these visits
- BCVA (visual acuity)
- endothelial cells microscopy
- OCT macula and optic nerve
- Catquest 9SF;
- Barthel Index;
- Six Item Cognitive Test
- Confusion Assessment Method (CAM): this exam will be performed within 24 hours of post-surgery and 20 days after surgery.
It is important to underline that the cognitive tests proposed to patients consist of simple questions that do not depend on the visual ability of the subject.
详细描述
Study design: prospective, monocentric, epidemiological study: non-interventional. The drafting of the protocol follows the order proposed by the STROBE check-list for the publication of the observational studies where applicable.
There is no agreement between promoter and clinical center.
There is no agreement between promoter and financier: the study has no funding. The study is also carried out for the purpose of completing a thesis.
Rational
The constant aging of the population in western countries has led to an increase in the incidence of visual deficits in the elderly, the incidence of cataract is around 68%, at the same time this category of subjects frequently has cognitive deficits that can be minimal or severe as in the case of dementias.
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
- 是
入选标准
- •Patients with age ≥ 65 years undergoing cataract surgery. Cataract surgery is indicated by the medical-scientific community according to good clinical practice and not influenced by the study's criteria. The purpose of the study is to add clinical-scientific information of any relevance.
排除标准
- •Patient refusal
- •Diagnosis of dementia by the specialist in neurocognitive diseases (neurologist and / or geriatrician)
- •maculopaties and other ophthalmopaties (according to diagnosis of ophthalmologist specialist) because the visual capacity is invalidated regardless of the opacification of the crystalline and therefore the cognitive function is not affected by a post-intervention improvement.
- •Patients who have performed cataract surgery in at least one eye since the previous cataract operation may have already caused changes in cognitive function causing confusion about the results of the study.
结局指标
主要结局
Correlation between visual acuity and cognitive function at 3 months after Cataract Surgery.
时间窗: 6 months before surgery to 3 months after surgey
The visual acuity trend and the cognitive function using the Kingshill (6CIT) score are measured during every visit. The 6 Item Cognitive Impairment Test (6CIT) is a test that doesn't provide the visual function. The choice of this kind of test resides in the capability of evaluating the cognitive function without any influence caused by cataract. The score is composed by 6 questions which evaluate the work memory, the temporal and spatial orientation. The test's result is a score, with a clinical cut-off of 7 points. The more points the subject makes, the higher risk of cognitive impairment is configured. The visual acuity is calculated with Snellen Chart using the Best Corrected Visual Acuity (BCVA) with the number of letters read.
次要结局
- Corneal endothelial cells density(6 months before surgery, 20 days after cataract surgery and 3 months after cataract surgery.)
- Post operative delirium prevalence(Only during the perioperative period (day of cataract surgery and the next 48 hours))
- Corneal pachymetry(6 months before surgery, 20 days after cataract surgery and 3 months after cataract surgery.)
研究者
Gian Maria Cavallini
Associate Professor, Head of Ophthalmology, Director, School of Specialization in Ophthalmology.
University of Modena and Reggio Emilia