ClinicalTrials.gg
CompletedNCT04311801Updated Mar 17, 2020

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

An interventional study of Optical Coherence Tomography in Change; Retina, sponsored by Masaryk Hospital Usti nad Labem. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-03-17.

Sponsored by Masaryk Hospital Usti nad Labem · Not applicable, Interventional, and Other

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Jan 2017, registered Feb 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Change; Retina
03

In context

Lead sponsor

Masaryk Hospital Usti nad Labem is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age over 18
  • Signed
  • Elective operation

Exclusion criteria

Exclusion Criteria:

  • Age under 18
  • Refusal to sign
  • Non-elective operation
  • Hospitalization on ICU more than 48 hours after surgery Inability to undergo OCT examination Protocol violation
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

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Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    OCT Arm

    Each patient underwent OCT examinations.

    Diagnostic Test: Optical Coherence Tomography

Interventions

  • Diagnostic testOptical Coherence Tomography

    Every patient underwent OCT examination before and after surgery.

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What researchers measure

Primary outcomes

  1. Retinal changes

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

    Time frame: 4.-7. day post surgery

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Study locations

No study locations are listed for this record.

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References and documents

Publications

  • 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. PubMed 20007988 ↗
  • 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. PubMed 29018702 ↗
  • 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. PubMed 33885047 ↗
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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Jan 2017 to primary completion in Jan 2018, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 18, 2020
First posted
Mar 17, 2020
StartActual
Jan 2017
Primary completionActual
Jan 2018
CompletionActual
Jan 2019
Last update
Mar 17, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04311801
Lead sponsor
Masaryk Hospital Usti nad Labem
Responsible party
Tomas Parizek (Principal Investigator, Masaryk Hospital Usti nad Labem) — Principal investigator
First posted
Mar 17, 2020
Start date
Jan 2017
Primary completion
Jan 2018
Completion
Jan 2019
Last update
Mar 17, 2020

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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