Change; RetinaNCT04311801
Optical Coherence Tomography (OCT) in Elderly Patients After Elective Orthopaedic Surgery
A study testing Optical Coherence Tomography in people with Change; Retina, run by Masaryk Hospital Usti nad Labem.
Trial 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 more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Change; Retina
- What is being tested?
- Optical Coherence Tomography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age over 18
- Signed informed consent
- Elective operation
Who cannot join
- 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
About this study
Official title: 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.
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.
- Conditions
- Change; Retina
- Being tested
- Optical Coherence Tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence TomographyDiagnostic test
Every patient underwent OCT examination before and after surgery.
| Study group | Role | What they receive |
|---|---|---|
| OCT Arm | Experimental | Each patient underwent OCT examinations. Receives: Diagnostic Test: Optical Coherence Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retinal changes
Patients undergo OCT (Optical Coherence Tomography) examination of both eyes before and after the surgery.
Measured: 4.-7. day post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study startJan 2017
- Primary completionJan 2018
- Study completionJan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Change; RetinaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masaryk Hospital Usti nad Labem
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tomas Parizek, Masaryk Hospital Usti nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311801
- Sponsor's protocol ID
- OCT
- Status last verified
- Mar 2020
- First submitted
- 18 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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 20007988Gupta 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 29018702Parizek 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
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optical Coherence Tomography in Elderly Patients After Elective Orthopaedic Surgery
- ClinicalTrials.gov ID
- NCT04311801
- Acronym / sponsor ID
- OCT
- Conditions
- Change; Retina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Masaryk Hospital Usti nad LabemUniversity, hospital or other
- Study start
- Jan 2017 (actual)
- Primary completion
- Jan 2018 (actual)
- Study completion
- Jan 2019 (actual)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| OCT Arm | Experimental | Diagnostic Test: Optical Coherence TomographyEach patient underwent OCT examinations. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age over 18
- Signed informed consent
- Elective operation
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence TomographyEvery patient underwent OCT examination before and after surgery. | Diagnostic test | OCT Arm |
Primary outcome
Retinal changes
Time frame: 4.-7. day post surgery
Patients undergo OCT (Optical Coherence Tomography) examination of both eyes before and after the surgery.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Background: PubMed 20007988Roth 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.
- Background: PubMed 29018702Gupta 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.
- Derived from this study: PubMed 33885047Parizek 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.
- American Society of Anesthesiologists (ASA) classificationLink provided by the sponsor.
- OCT in clinical practiceLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography in people with Change; Retina, run by Masaryk Hospital Usti nad Labem.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retinal changes (time frame: 4.-7. day post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04311801, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Mar 2020.