Raised Ocular PressureIOPNCT02342288
Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
A study testing Head raised 10 degrees and Head in neutral position in people with Raised Ocular Pressure, run by West Virginia University.
Trial summary
A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Raised Ocular Pressure
- What is being tested?
- Head raised 10 degrees and Head in neutral position
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 79 participants
- Where
- No sites listed yet
- Study dates
- Jul 2008to Feb 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing elective lumbar spinal fusion surgery; ages 18-80
Who cannot join
- Less than 18 years of age
- Glaucoma, previous eye surgery, eye injury, or eye trauma, cervical myelopathy, prior cervical spine surgery, current neoplasm, patients who have neck pain with 10 degrees active extension.
About this study
A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss. It has been shown that the prone position can increase the IOP, and that tilting the patient with the head down can also increase IOP. The investigators will be measuring IOP before, during, and after a posterior spine surgery to see if the investigators can influence the intraocular pressure with elevated head position change. Two groups will be studied: one group of patients will receive standard care with the head in neutral position, while the other group will have the head slightly elevated 10 degrees during prone spine surgery.
Read the detailed description
It has been reported that postoperative vision loss after lumbar surgery is increasing. It is an uncommon but devastating complication. One of the risk factors that has been reported is increased intraocular pressure (IOP), which may decrease perfusion pressure to the optic nerve. Intraocular pressure in anesthetized, prone spine patients has been studied with the head in neutral position. The prone position and duration of the procedure did increase the IOP. Our hypothesis is that adjusting the position of the head in space will alter the intraocular pressure, with an extended position decreasing IOP. This study is a, randomized, controlled design: neutral head position (standard care) or extended head position (intervention group). Patients who qualify for spinal fusion surgery and meet the inclusion criteria will be randomized to either the neutral (standard practice) or the intervention group.Randomization of patients will be computer generated.
- Conditions
- Raised Ocular Pressure
- Being tested
- Head raised 10 degrees, Head in neutral position
- Keywords
- Intraoperative ocular pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Head raised 10 degreesProcedure or surgery
Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
Head in neutral positionProcedure or surgery
Baseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration.
| Study group | Role | What they receive |
|---|---|---|
| Head raised 10 degrees | Experimental | Head raised 10 degrees from neutral position using Gardner Wells tongs Receives: Procedure: Head raised 10 degrees |
| Head in neutral position | Active comparator | Head in neutral position Receives: Procedure: Head in neutral position |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position
The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP - two eye average baseline IOP obtained at first prone measurement).
Measured: Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery
Secondary outcomes (1)
Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
The secondary outcome is to evaluate factors (age, gender, duration of procedure, blood loss, intraoperative fluids, blood pressure, and carbon dioxide levels) looking for correlations with intraocular pressure changes.
Measured: prone; every 15 minutes; 1 hr until end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2015 (estimated)
- Study startJul 2008
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Raised Ocular PressureStudies of the same condition, open and under way.
- More trials run by West Virginia UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 79 participants (actual)
Sponsor and investigators
- Lead sponsor
- West Virginia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sanford E Emery, MD, MBA, West Virginia University
- Investigators
- Sanford E Emery, MD, MBA, Principal investigator, West Virginia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342288
- Sponsor's protocol ID
- 1409441146
- Acronym
- IOP
- Status last verified
- Jan 2016
- First submitted
- 8 Jan 2015
- Last updated
- 24 Feb 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: Group data will be published. Not individual data.
Publications
Ozcan MS, Praetel C, Bhatti MT, Gravenstein N, Mahla ME, Seubert CN. The effect of body inclination during prone positioning on intraocular pressure in awake volunteers: a comparison of two operating tables. Anesth Analg. 2004 Oct;99(4):1152-1158. doi: 10.1213/01.ANE.0000130851.37039.50.
PubMed 15385367Carey TW, Shaw KA, Weber ML, DeVine JG. Effect of the degree of reverse Trendelenburg position on intraocular pressure during prone spine surgery: a randomized controlled trial. Spine J. 2014 Sep 1;14(9):2118-26. doi: 10.1016/j.spinee.2013.12.025. Epub 2014 Jan 20.
PubMed 24456677Walick KS, Kragh JE Jr, Ward JA, Crawford JJ. Changes in intraocular pressure due to surgical positioning: studying potential risk for postoperative vision loss. Spine (Phila Pa 1976). 2007 Nov 1;32(23):2591-5. doi: 10.1097/BRS.0b013e318158cc23.
PubMed 17978659Emery SE, Daffner SD, France JC, Ellison M, Grose BW, Hobbs GR, Clovis NB. Effect of Head Position on Intraocular Pressure During Lumbar Spine Fusion: A Randomized, Prospective Study. J Bone Joint Surg Am. 2015 Nov 18;97(22):1817-23. doi: 10.2106/JBJS.O.00091.
PubMed 26582611
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
- ClinicalTrials.gov ID
- NCT02342288
- Acronym / sponsor ID
- IOP / 1409441146
- Conditions
- Raised Ocular Pressure
- Keywords
- Intraoperative ocular pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 79 participants (actual)
- Lead sponsor
- West Virginia UniversityUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 19 Jan 2015 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A rare but terrible complication of vision loss has been known to occur after surgery, including spine surgery. It is commonly thought that increased intraocular pressure (IOP) is one of the reasons for this rare vision loss. It has been shown that the prone position can increase the IOP, and that tilting the patient with the head down can also increase IOP. The investigators will be measuring IOP before, during, and after a posterior spine surgery to see if the investigators can influence the intraocular pressure with elevated head position change. Two groups will be studied: one group of patients will receive standard care with the head in neutral position, while the other group will have the head slightly elevated 10 degrees during prone spine surgery.
Detailed description
It has been reported that postoperative vision loss after lumbar surgery is increasing. It is an uncommon but devastating complication. One of the risk factors that has been reported is increased intraocular pressure (IOP), which may decrease perfusion pressure to the optic nerve. Intraocular pressure in anesthetized, prone spine patients has been studied with the head in neutral position. The prone position and duration of the procedure did increase the IOP. Our hypothesis is that adjusting the position of the head in space will alter the intraocular pressure, with an extended position decreasing IOP. This study is a, randomized, controlled design: neutral head position (standard care) or extended head position (intervention group). Patients who qualify for spinal fusion surgery and meet the inclusion criteria will be randomized to either the neutral (standard practice) or the intervention group.Randomization of patients will be computer generated.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head raised 10 degrees | Experimental | Procedure: Head raised 10 degreesHead raised 10 degrees from neutral position using Gardner Wells tongs |
| Head in neutral position | Active comparator | Procedure: Head in neutral positionHead in neutral position |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective lumbar spinal fusion surgery; ages 18-80
Key exclusion criteria (2 listed)
- Less than 18 years of age
- Glaucoma, previous eye surgery, eye injury, or eye trauma, cervical myelopathy, prior cervical spine surgery, current neoplasm, patients who have neck pain with 10 degrees active extension.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Head raised 10 degreesBaseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. Head was raised to 10 degrees. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration. | Procedure or surgery | Head raised 10 degrees |
| Head in neutral positionBaseline measurement in seated position; anesthetization in the supine position. Prior to turning into the prone position, another measurement was taken. Five minutes after turning prone, a third IOP measurement was obtained. After 5 minutes a fourth IOP measurement was performed. Repeat measurements were taken every 15 minutes until three sequential measurements were within plus or minus 3 mmHg of one another; thereafter, measurements were obtained every hour until end of case. A final measurement was taken after turning the patient supine and 5 minutes elapsed for equilibration. | Procedure or surgery | Head in neutral position |
Primary outcome
Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position
Time frame: Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery
The objective is to determine if slight elevation of the head (10 degrees up from neutral) can decrease the IOP compared to remaining in neutral position (standard of care) for the entire surgery. The mean values for Δ IOP measurements (i.e. two eye average maximum IOP - two eye average baseline IOP obtained at first prone measurement).
1 secondary outcome
Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Time frame: prone; every 15 minutes; 1 hr until end of surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15385367Ozcan MS, Praetel C, Bhatti MT, Gravenstein N, Mahla ME, Seubert CN. The effect of body inclination during prone positioning on intraocular pressure in awake volunteers: a comparison of two operating tables. Anesth Analg. 2004 Oct;99(4):1152-1158. doi: 10.1213/01.ANE.0000130851.37039.50.
- Background: PubMed 24456677Carey TW, Shaw KA, Weber ML, DeVine JG. Effect of the degree of reverse Trendelenburg position on intraocular pressure during prone spine surgery: a randomized controlled trial. Spine J. 2014 Sep 1;14(9):2118-26. doi: 10.1016/j.spinee.2013.12.025. Epub 2014 Jan 20.
- Background: PubMed 17978659Walick KS, Kragh JE Jr, Ward JA, Crawford JJ. Changes in intraocular pressure due to surgical positioning: studying potential risk for postoperative vision loss. Spine (Phila Pa 1976). 2007 Nov 1;32(23):2591-5. doi: 10.1097/BRS.0b013e318158cc23.
- Derived from this study: PubMed 26582611Emery SE, Daffner SD, France JC, Ellison M, Grose BW, Hobbs GR, Clovis NB. Effect of Head Position on Intraocular Pressure During Lumbar Spine Fusion: A Randomized, Prospective Study. J Bone Joint Surg Am. 2015 Nov 18;97(22):1817-23. doi: 10.2106/JBJS.O.00091.
- Individual participant dataSharing planned: No. Group data will be published. Not individual data.
Related trials for Raised Ocular Pressure
Not yet recruitingObservational study
Bedside Ultrasound Measurement of Optic Nerve Sheath Diameter for Detecting Raised Intracranial Pressure
Intracranial Hypertension, Increased Intracranial Pressure
Not yet recruitingObservational study
Diagnostic Accuracy of Bedside Optic Nerve Sheath Diameter Ultrasonography for Detecting Raised Intracranial Pressure Compared With Brain CT Findings in Children With Traumatic Brain Injury
Traumatic Brain Injury
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. This study is not recruiting at the moment.
Sanford E Emery, MD, MBA principal investigator
West Virginia University
Questions about this trial
What is this clinical trial studying?
A study testing Head raised 10 degrees and Head in neutral position in people with Raised Ocular Pressure, run by West Virginia University.
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 1 inclusion and 2 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: finished, as of the sponsor's last update on 24 Feb 2016. 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?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position (time frame: Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery). 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 NCT02342288, which also lists 4 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 24 Feb 2016.