Evaluation of the Effect of Cataract Surgery on Cognitive Function in Very Elderly Patients

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.

Conditions

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

Interventions

DIAGNOSTIC_TEST

Visual Acuity

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

DIAGNOSTIC_TEST

CAM (Confusion Assesment Method)

During the first 48 hours of post-op follow-up, any episode of "post-operative Delirium" is checked and evaluated.

DIAGNOSTIC_TEST

CATQUEST 9-SF

The questionnaire contains questions evaluating the benefits of cataract surgery. The questionnaire has been used during T0, T2 and T3

DIAGNOSTIC_TEST

OCT

Using the RNFL and the Macular Topography protocol, the macula and optical nerve are measured during the T2 phase of each patient the risk of Irvine Gas's syndrome or any other retinal complication.

DIAGNOSTIC_TEST

6CIT

This Cognitive Impairment test doesn't require Visual function to be executed. Cognitive function is evaluated at T0, T1 and the post-operative trend at T2 and T3.

DIAGNOSTIC_TEST

Barthel Index

To evaluate the everyday independence of the subject and it's trend durin the follow-up

DIAGNOSTIC_TEST

Endothelial Microscopy - Cornea

Endothelial cell density is evaluated before surgery (T0) and during the follow-up (T2 and T3). The reason of the choice of this test is to evaluate the trend of these instrumental parameters in the elderly population.

Sponsors & Collaborators

• University of Modena and Reggio Emilia

  lead OTHER

Principal Investigators

• Gian Maria Cavallini, Associate Professor · Dipartimento Chirurgico, Medico, Odontoiatrico e di Scienze Morfologiche con interesse Trapiantologico, Oncologico e di Medicina Rigenerativa - UNIMORE - University of Modena and Reggio Emilia

Eligibility

Min Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-02-02

Primary Completion

2020-02-28

Completion

2020-03-30

Countries

• Italy

Study Locations