NCT04311801

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2018

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2020

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 17, 2020

Completed
Last Updated

March 17, 2020

Status Verified

March 1, 2020

Enrollment Period

1 year

First QC Date

February 18, 2020

Last Update Submit

March 15, 2020

Conditions

Change; Retina

Outcome Measures

Primary Outcomes (1)

  • Retinal changes

    Patients undergo OCT (Optical Coherence Tomography) examination of both eyes before and after the surgery.

    4.-7. day post surgery

Study Arms (1)

OCT Arm

EXPERIMENTAL

Each patient underwent OCT examinations.

Diagnostic Test: Optical Coherence Tomography

Interventions

Optical Coherence TomographyDIAGNOSTIC_TEST

Every patient underwent OCT examination before and after surgery.

OCT Arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18
  • Signed informed consent
  • Elective operation

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • 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.

    PMID: 20007988BACKGROUND

  • 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.

    PMID: 29018702BACKGROUND

  • Parizek T, Skulec R, Liehneova I, Prasek P, Cerny V. No significant retinal damage induced by major orthopedic surgery - a pilot study. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 May;166(2):217-221. doi: 10.5507/bp.2021.022. Epub 2021 Apr 19.

    PMID: 33885047DERIVED

Related Links

MeSH Terms

Interventions

Tomography, Optical Coherence

Intervention Hierarchy (Ancestors)

Tomography, OpticalOptical ImagingDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisTomographyInvestigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 18, 2020

First Posted

March 17, 2020

Study Start

January 1, 2017

Primary Completion

January 1, 2018

Study Completion

January 1, 2019

Last Updated

March 17, 2020

Record last verified: 2020-03