Clinical trial NCT02342288: Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Official title: Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Raised Ocular Pressure
Keywords: Intraoperative ocular pressure
Lead sponsor: West Virginia University
Sponsor class: OTHER
First posted: 2015-01-19
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* Patients undergoing elective lumbar spinal fusion surgery; ages 18-80

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients Head Raised 10 Degrees or Kept in Neutral Position
timeFrame: Prone; 5 minutes after head raised to 10 degrees; every 15 minutes; 1 hr until end of surgery
Secondary outcomes:
measure: Change and Correlations in Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients
timeFrame: prone; every 15 minutes; 1 hr until end of surgery
Other outcomes:
Locations:
Study officials:
affiliation: West Virginia University
name: Sanford E Emery, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Carey 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.
citation: Walick 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.
citation: Emery 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.