- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07395115
A Prospective Observational Study on Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity in Prone Spinal Surgery (PRONE-ONSD)
Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity Changes in Adult Patients Undergoing Prone Spine Surgery: A Prospective Observational Study
Study Overview
Status
Conditions
Detailed Description
During spine surgery, many patients are positioned face-down (prone position) for several hours. This position may influence blood flow to the head and increase pressure around the brain and eyes. One structure that can reflect these pressure changes is the optic nerve sheath, which surrounds the optic nerve at the back of the eye. When the pressure inside the skull rises, the optic nerve sheath may become wider. This change can be measured non-invasively using ultrasound and is referred to as optic nerve sheath diameter (ONSD).
This prospective observational study will evaluate whether ONSD changes occur in adult patients undergoing prone-position spine surgery and whether these changes are related to temporary alterations in vision. Visual acuity will be evaluated using a standard Snellen chart before surgery and on the first postoperative day to detect any change in vision after the procedure.
Ultrasound ONSD measurements will be performed in three stages: before the patient is placed in the prone position, shortly after the prone position is established, and at the end of the surgery while still in the same position. Clinical variables such as blood pressure, carbon dioxide levels, ventilation parameters, anesthesia technique, the use of a pinned head holder, and patient characteristics will also be recorded. By comparing these variables with ONSD and visual outcomes, the study aims to identify whether specific surgical or physiological factors contribute to increased optic nerve sheath width or temporary vision disturbances.
This research does not involve any experimental drug or device. All measurements are part of routine safe monitoring techniques used to assess patients' condition during surgery. The goal of this study is to help better understand factors that may increase the risk of eye-related complications during prone spine surgery and to contribute to safer surgical practices.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Istanbul, Turkey (Türkiye)
- Istanbul University - Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age ≥ 18 years
- Scheduled to undergo elective spine surgery in the prone position
- American Society of Anesthesiologists (ASA) physical status I-III
- Preoperative visual acuity measurable using a Snellen chart
Exclusion Criteria:
- Preexisting ophthalmologic diseases affecting optic nerve or visual acuity (e.g., glaucoma, optic neuropathy, diabetic retinopathy)
- Previous eye trauma or history of orbital surgery
- Inability to obtain reliable ultrasonographic ONSD measurements (e.g., orbital deformity, ocular infection)
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Prone Spine Surgery Cohort
Adults undergoing prone-position spine surgery, evaluated with ultrasound ONSD measurements and visual acuity testing.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in ultrasonographic optic nerve sheath diameter (mm)
Time Frame: Baseline (preoperative, supine), after prone positioning (15 minutes after positioning), and at the end of surgery (intraoperative, before repositioning to supine).
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Optic nerve sheath diameter (ONSD) will be measured bilaterally using standardized transorbital ultrasonography with a high-frequency linear probe (6-13 MHz).
Measurements will be obtained 3 mm posterior to the globe, in accordance with established sonographic guidelines.
For each eye, three measurements will be recorded, and the mean value will be calculated.
The average of both eyes will be used for statistical analysis.
The primary outcome will be the absolute change in ONSD (ΔONSD, mm) between baseline and intraoperative prone measurements.
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Baseline (preoperative, supine), after prone positioning (15 minutes after positioning), and at the end of surgery (intraoperative, before repositioning to supine).
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Change in visual acuity (logMAR)
Time Frame: Baseline (preoperative) and postoperative day 1.
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Visual acuity will be initially recorded in decimal format using a standard Snellen chart and subsequently converted to logMAR units for statistical analysis.
The outcome will be the absolute change in visual acuity (ΔlogMAR) from baseline to postoperative day 1 (postoperative logMAR minus baseline logMAR).
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Baseline (preoperative) and postoperative day 1.
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Correlation between change in ONSD and intraoperative end-tidal carbon dioxide (EtCO₂)
Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative end-tidal carbon dioxide levels (EtCO₂, mmHg) recorded simultaneously with ONSD measurements.
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Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Difference in ONSD change between pinned head holder and non-pinned positioning
Time Frame: ntraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Change in ONSD (mm) will be compared between patients positioned using a pinned head holder and those positioned without pin fixation.
The outcome will be the between-group difference in ONSD change (mm).
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ntraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Association between postoperative visual acuity change and intraoperative ONSD change
Time Frame: Baseline (preoperative) and postoperative day 1.
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The association between postoperative change in visual acuity (ΔlogMAR) and intraoperative change in optic nerve sheath diameter (ΔONSD) will be evaluated using regression analysis.
Visual acuity will be recorded in decimal format and converted to logMAR for statistical analysis.
ONSD will be measured using standardized transorbital ultrasonography and expressed in millimeters.
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Baseline (preoperative) and postoperative day 1.
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Correlation between change in ONSD and intraoperative mean arterial pressure (MAP)
Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative mean arterial pressure (MAP, mmHg) recorded simultaneously with ONSD measurements.
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Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation between change in ONSD and intraoperative arterial partial pressure of carbon dioxide (PaCO₂)
Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and arterial partial pressure of carbon dioxide (PaCO₂, mmHg) obtained from arterial blood gas analysis and recorded simultaneously with ONSD measurements.
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Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation between change in ONSD and intraoperative arterial partial pressure of oxygen (PaO₂)
Time Frame: Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and arterial partial pressure of oxygen (PaO₂, mmHg) obtained from arterial blood gas analysis and recorded simultaneously with ONSD measurements.
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Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation between change in ONSD and intraoperative positive end-expiratory pressure (PEEP)
Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative positive end-expiratory pressure levels (PEEP, cmH₂O) recorded simultaneously with ONSD measurements.
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Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Özlem Korkmaz Dilmen, MD, Prof, Istanbul University-Cerrahpasa, Cerrahpasa Medical Faculty
- Study Director: Begüm Ramakan, MD, Anesthesiology Resident, Istanbul University - Cerrahpasa
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2024/244
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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