NCT07067008

Brief Summary

Laminectomy surgeries, typically performed for lumbar disc herniation and spinal disorders, are often lengthy surgical procedures requiring patients to be in the prone position. While this position provides better visibility of the surgical field, it can lead to physiological changes in intraocular pressure (IOP) in anesthetized patients. An increase in IOP, though rare, has the potential to cause severe ocular complications such as postoperative vision loss (POVL), which is one of the most feared complications after spinal surgery. One of the main mechanisms of IOP elevation in the prone position is the impediment of venous return in the head and neck region due to gravity, leading to an increase in episcleral venous pressure. Additionally, direct mechanical pressure on the face and globe can also increase IOP. Anesthesia management can also play a role in IOP dynamics by affecting intrathoracic pressure and venous return. This complex interaction necessitates careful monitoring of eye health in anesthetized patients in the prone position. Non-contact tonometers offer a non-invasive, rapid, and reliable method for IOP measurement. They are particularly advantageous for repeated measurements in anesthetized patients. This clinical study aims to evaluate changes in IOP using a non-contact tonometer in patients undergoing laminectomy in the prone position and to identify anesthesia- and patient-related factors influencing these changes. The data obtained will contribute to the development of anesthesia and positioning strategies aimed at reducing the risk of ocular complications.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 4, 2025

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 15, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

August 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

July 18, 2025

Status Verified

July 1, 2025

Enrollment Period

2 months

First QC Date

July 4, 2025

Last Update Submit

July 15, 2025

Conditions

Keywords

Prone PositionIntraocular PressureLaminectomy

Outcome Measures

Primary Outcomes (1)

  • Intraoperative IOP Measurement Schedule After Induction: Intraocular pressure (IOP) is measured non-contact using a tonometer. Intraoperative 1st Hour: After Prone Positioning:

    half an hour

Study Arms (2)

Group 1 will include those with a BMI of 40 kg/m2 and above.

Group 2 will include those with a BMI below 40 kg/m2.

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients scheduled for laminectomy surgery under general anesthesia.

You may qualify if:

  • Patients scheduled for laminectomy surgery under general anesthesia
  • Patients with ASA physical status I-II-III
  • Patients who can cooperate postoperatively
  • Patients without eye diseases or conditions affecting eye physiology (such as glaucoma)
  • Patients who have not undergone eye surgery
  • Patients who consent to participate in the study

You may not qualify if:

  • Patients scheduled for laminectomy surgery but not receiving general anesthesia
  • Patients with ASA physical status IV-V
  • Patients who do not consent to participate in the study
  • Patients who cannot cooperate postoperatively
  • Patients with eye diseases or conditions affecting eye physiology (such as glaucoma)
  • Patients who have undergone eye surgery
  • Patients from whom consent cannot be obtained

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Kim YS, Seo KH, Jeon YS, In JH, Jung HS, Park YJ, Jun EH, Yu E. Effects of Positive End-Expiratory Pressure on Intraocular Pressure during One-Lung Ventilation in the Lateral Decubitus Position-A Prospective Randomized Trial. Medicina (Kaunas). 2022 Jul 15;58(7):940. doi: 10.3390/medicina58070940.

    PMID: 35888659BACKGROUND
  • Saoulidou EN, Giavi VD, Paidakakos NA, Papaconstantinou DS, Dimakopoulou AN, Matsota PK. Effect of Prone Position on Intraocular Pressure in Patients Undergoing Nonocular Surgery: A Systematic Review. Cureus. 2025 May 6;17(5):e83617. doi: 10.7759/cureus.83617. eCollection 2025 May.

    PMID: 40351490BACKGROUND

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2025

First Posted

July 15, 2025

Study Start

August 15, 2025

Primary Completion

October 15, 2025

Study Completion

October 30, 2025

Last Updated

July 18, 2025

Record last verified: 2025-07