LaminectomyNCT07067008
Measurement of Intraocular Pressure in Patients Undergoing Laminectomy in the Prone Position
An observational study of Laminectomy and Intraocular Pressure, run by Elazıg Fethi Sekin Sehir Hastanesi.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laminectomy, Intraocular Pressure, Prone Position
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Oct 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for laminectomy surgery under general anesthesia.
Who may be able to join
- 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
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Laminectomy, Intraocular Pressure, Prone Position
- Keywords
- Prone Position, Intraocular Pressure, Laminectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 will include those with a BMI of 40 kg/m2 and above. | Not described | |
| Group 2 will include those with a BMI below 40 kg/m2. | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative IOP Measurement Schedule After Induction: Intraocular pressure (IOP) is measured non-contact using a tonometer. Intraoperative 1st Hour: After Prone Positioning:
Measured: half an hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Oct 2025 (estimated)
- Study completion30 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for LaminectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Elazıg Fethi Sekin Sehir Hastanesi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07067008
- Sponsor's protocol ID
- FSCH-SB-2024/07
- Status last verified
- Jul 2025
- First submitted
- 4 Jul 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Researchers' Interests and Time Constraints
Publications
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.
PubMed 35888659Saoulidou 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.
PubMed 40351490
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of Intraocular Pressure (With Non-contact Tonometer) in Patients Undergoing Laminectomy in the Prone Position: A Clinical Study
- ClinicalTrials.gov ID
- NCT07067008
- Acronym / sponsor ID
- FSCH-SB-2024/07
- Conditions
- Laminectomy, Intraocular Pressure, Prone Position
- Keywords
- Prone Position, Intraocular Pressure, Laminectomy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Elazıg Fethi Sekin Sehir HastanesiUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Oct 2025 (estimated)
- Study completion
- 30 Oct 2025 (estimated)
- First posted
- 15 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for laminectomy surgery under general anesthesia.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Background: PubMed 35888659Kim 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.
- Results publication: PubMed 40351490Saoulidou 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.
- Individual participant dataSharing planned: Undecided. Researchers' Interests and Time Constraints
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Laminectomy and Intraocular Pressure, run by Elazıg Fethi Sekin Sehir Hastanesi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07067008, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2025.