Measurement of Intraocular Pressure in Patients Undergoing Laminectomy in the Prone Position

July 15, 2025 updated by: Elazıg Fethi Sekin Sehir Hastanesi

Measurement of Intraocular Pressure (With Non-contact Tonometer) in Patients Undergoing Laminectomy in the Prone Position: A Clinical Study

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.

Study Overview

Status

Not yet recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

60

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

Probability Sample

Study Population

Patients scheduled for laminectomy surgery under general anesthesia.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Intraoperative IOP Measurement Schedule After Induction: Intraocular pressure (IOP) is measured non-contact using a tonometer. Intraoperative 1st Hour: After Prone Positioning:
Time Frame: half an hour
half an hour

Collaborators and Investigators

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

Sponsor

Elazıg Fethi Sekin Sehir Hastanesi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

August 15, 2025

Primary Completion (Estimated)

October 15, 2025

Study Completion (Estimated)

October 30, 2025

Study Registration Dates

First Submitted

July 4, 2025

First Submitted That Met QC Criteria

July 4, 2025

First Posted (Actual)

July 15, 2025

Study Record Updates

Last Update Posted (Actual)

July 18, 2025

Last Update Submitted That Met QC Criteria

July 15, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FSCH-SB-2024/07

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Researchers' Interests and Time Constraints

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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