Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date

Enrollment

100

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Feb 2019

Geographic Reach

1 country

1 active site

Status

unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.2 years study duration

Study Start

First participant enrolled

February 2, 2019

Completed

6 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2019

Completed

12 days until next milestone

First Posted

Study publicly available on registry

August 6, 2019

Completed

7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2020

Completed

1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

March 30, 2020

Completed

Last Updated

August 6, 2019

Status Verified

August 1, 2019

Enrollment Period

1.1 years

First QC Date

July 25, 2019

Last Update Submit

August 5, 2019

Conditions

Dementia Mild Cognitive Impairment Cataract Senile Cataract Delirium in Old Age Delirium Confusional State Post-Op Complication Cataract in Old Age

Keywords

CataractMild Cognitive Impairment (MCI)Cataract SurgeryBMICS (Bi-Manual Microincisional Cataract Surgery)Post-operative Delirium

Outcome Measures

Primary Outcomes (1)

Correlation between visual acuity and cognitive function at 3 months after Cataract Surgery.
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.
6 months before surgery to 3 months after surgey

Secondary Outcomes (3)

Post operative delirium prevalence
Only during the perioperative period (day of cataract surgery and the next 48 hours)
Corneal endothelial cells density
6 months before surgery, 20 days after cataract surgery and 3 months after cataract surgery.
Corneal pachymetry
6 months before surgery, 20 days after cataract surgery and 3 months after cataract surgery.

Study Arms (4)

Elderly Female (A)

Female subjects between 65 and 85 years old

Diagnostic Test: Visual AcuityDiagnostic Test: CAM (Confusion Assesment Method)Diagnostic Test: CATQUEST 9-SFDiagnostic Test: OCTDiagnostic Test: 6CITDiagnostic Test: Barthel IndexDiagnostic Test: Endothelial Microscopy - Cornea

Great Elderly Female (B)

Female subjects with more than 85 years old

Elderly Male (C)

Male subjects between 65 and 81 years old

Great Elderly Male (D)

Men subjects with more than 81 years old

Interventions

Visual AcuityDIAGNOSTIC_TEST

During T0, T2 and T3, every subject has been evaluated with a Snellen Chart, to measure visual acuity in number of letters (BVCA)