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NCT Number: NCT07395115

A Prospective Observational Study on Factors Affecting Optic Nerve Sheath Diameter and Visual Acuity in Prone Spinal Surgery

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Istanbul University - Cerrahpaşa, Cerrahpaşa Faculty of Medicine Hospital

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. 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.

  3. 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).

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

Sponsors and collaborators

Lead sponsor

Istanbul University - Cerrahpasa

Other

Registry information

Official study title

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

Acronym: PRONE-ONSD

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 9, 2026
Registry last updated
Feb 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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