A Prospective Observational Study on Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity in Prone Spinal Surgery (PRONE-ONSD)

February 3, 2026 updated by: Begüm Ramakan, MD, Istanbul University - Cerrahpasa

Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity Changes in Adult Patients Undergoing Prone Spine Surgery: A Prospective Observational Study

The prone position in spinal surgery can alter intracranial pressure and optic nerve sheath diameter (ONSD) and potentially lead to visual complications. This prospective observational study aimed to identify factors influencing ultrasonographic ONSD changes and visual acuity in patients undergoing spinal surgery.

Study Overview

Status

Completed

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

Observational

Enrollment (Actual)

65

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Istanbul, Turkey (Türkiye)
        • Istanbul University - Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients scheduled for elective spine surgery requiring prone positioning at a university hospital setting.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Prone Spine Surgery Cohort
Adults undergoing prone-position spine surgery, evaluated with ultrasound ONSD measurements and visual acuity testing.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
Baseline (preoperative, supine), after prone positioning (15 minutes after positioning), and at the end of surgery (intraoperative, before repositioning to supine).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in visual acuity (logMAR)
Time Frame: Baseline (preoperative) and postoperative day 1.
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).
Baseline (preoperative) and postoperative day 1.
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.
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.
Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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.
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).
ntraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
Association between postoperative visual acuity change and intraoperative ONSD change
Time Frame: Baseline (preoperative) and postoperative day 1.
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.
Baseline (preoperative) and postoperative day 1.
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.
Correlation analysis will be performed between changes in ONSD (ΔONSD, mm) and intraoperative mean arterial pressure (MAP, mmHg) recorded simultaneously with ONSD measurements.
Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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.
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.
Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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.
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.
Time Frame: Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.
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.
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.
Intraoperative period: baseline (supine), after prone positioning (15 minutes), and at the end of surgery.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 3, 2024

Primary Completion (Actual)

June 4, 2025

Study Completion (Actual)

June 5, 2025

Study Registration Dates

First Submitted

December 3, 2025

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 9, 2026

Study Record Updates

Last Update Posted (Actual)

February 9, 2026

Last Update Submitted That Met QC Criteria

February 3, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 2024/244

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

IPD will not be shared because individual-level data are not permitted to be disclosed under the current ethical approval.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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