Optical Coherence Tomography (OCT) in Elderly Patients Af... | NCT04311801

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

NCT04311801

Sponsor

Masaryk Hospital Usti nad Labem

Status

Completed

Last Update Posted

Mar 17, 2020Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Change; Retina

Interventions

Optical Coherence Tomography

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2017Actual

Primary Completion Date

Jan 2018Actual

Completion Date

Jan 2019Actual

First Submitted Date

Feb 18, 2020

First Submission Date that Met QC Criteria

Mar 15, 2020

First Posted Date

Mar 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 15, 2020

Last Update Posted Date

Mar 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Tomas Parizek, Principal Investigator, Masaryk Hospital Usti nad LabemPrincipal Investigator

Lead Sponsor

Masaryk Hospital Usti nad LabemOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
OCT Arm	Experimental	Each patient underwent OCT examinations.	Diagnostic Test: Optical Coherence Tomography

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Optical Coherence Tomography	Diagnostic Test	Every patient underwent OCT examination before and after surgery.	OCT Arm

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
20007988	Background	Roth S. Perioperative visual loss: what do we know, what can we do? Br J Anaesth. 2009 Dec;103 Suppl 1(Suppl 1):i31-40. doi: 10.1093/bja/aep295.
29018702	Background	Gupta D, Asrani S. Macular thickness analysis for glaucoma diagnosis and management. Taiwan J Ophthalmol. 2016 Jan-Mar;6(1):3-7. doi: 10.1016/j.tjo.2016.01.003. Epub 2016 Feb 28.

ID	Term
D041622	Tomography, Optical
D061848	Optical Imaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures