Optical Coherence Tomography (OCT) in Elderly Patients After Elective Orthopaedic Surgery

March 15, 2020 updated by: Tomas Parizek, Masaryk Hospital Usti nad Labem

Optical Coherence Tomography in Elderly Patients After Elective Orthopaedic Surgery

After obtaining informed consent each patient underwent OCT examination, usually one day before elective orthopaedic surgery (knee replacement). The OCT examination was repeated after the surgery. Both eyes were examined separately. After obtaining data the investigators compared the difference.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Inclusion and exclusion criteria evaluated during the pre-anesthesia visit. After obtaining informed consent, patients were referred to OCT examination in the Ophthalmology clinic. The examination was performed in the 48 hours before the surgery. Between the fourth and the seventh postoperative day, the patients underwent control OCT examination. The results of OCT examinations, baseline clinical data and the data on the course of surgery and postoperative care were recorded for further analysis.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age over 18
  • Signed informed consent
  • Elective operation

Exclusion Criteria:

  • Age under 18
  • Refusal to sign informed consent
  • Non-elective operation
  • Hospitalization on ICU more than 48 hours after surgery Inability to undergo OCT examination Protocol violation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: OCT Arm
Each patient underwent OCT examinations.
Diagnostic test: Optical Coherence Tomography
Every patient underwent OCT examination before and after surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Retinal changes
Time Frame: 4.-7. day post surgery
Patients undergo OCT (Optical Coherence Tomography) examination of both eyes before and after the surgery.
4.-7. day post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Masaryk Hospital Usti nad Labem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ACTUAL)

January 1, 2018

Study Completion (ACTUAL)

January 1, 2019

Study Registration Dates

First Submitted

February 18, 2020

First Submitted That Met QC Criteria

March 15, 2020

First Posted (ACTUAL)

March 17, 2020

Study Record Updates

Last Update Posted (ACTUAL)

March 17, 2020

Last Update Submitted That Met QC Criteria

March 15, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • OCT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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