Intraocular Pressure Clinical Trial
Official title:
Continuous Intraocular Pressure Patterns in Spine Surgery
NCT number | NCT03299400 |
Other study ID # | UW 16-207 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | May 9, 2016 |
Est. completion date | May 9, 2017 |
Verified date | May 2020 |
Source | The University of Hong Kong |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Post-operative visual loss is a rare but serious complication after surgery. It is most
significantly correlated with prone spinal surgery with a prolonged duration. The cause and
risk factors are not elucidated, but the majority of the cases are due posterior ischaemic
optic neuropathy (PION). This entity is directly related to the ocular perfusion pressure
(OPP), which is estimated as the difference between mean arterial blood pressure (MAP) and
intraocular pressure (IOP). Autoregulation is believed to maintain a constant perfusion to
the optic nerve despite fluctuations in the perfusion pressure.
IOP is known to increase in the prone position thus putting susceptible patients at risk for
inadequate ocular nerve perfusion. Most of the evidence comes from animal and healthy
volunteer studies and cannot give an accurate insight into the subtle changes of
intra-operative IOP. All the published studies employed the use of a tonometer, which may
have rooms for measurement errors due to inadvertent pressure on the globe while retracting
the eyelids, particularly when there is significant periorbital/conjunctival swelling in the
prone position. The majority of the studies recruited healthy volunteers in a simulated
surgical setting so other fluctuating parameters, which can affect intraoperative IOP, cannot
be measured. In the few reports where patients undergoing surgery in the prone position were
studies, IOP measurements were taken at non-continuous monitoring at time intervals, thus the
effects of changes in blood volume, MAP, central venous pressure (CVP) and PaCO 2 could not
be studied. Lastly, all the literature consists of case series only with no control group so
the effect of position cannot be evaluated independently of the other factors.
The investigators therefore propose to conduct a prospective study with continuous
intraoperative IOP monitoring to give us further insight into the physiological changes of
IOP in patients undergoing spine surgery, and identify the risk factors related to
fluctuations of IOP during prone spinal surgery.
Status | Completed |
Enrollment | 10 |
Est. completion date | May 9, 2017 |
Est. primary completion date | May 9, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Signed informed consent - Age 18 to 80 years inclusive - No pre-existing eye pathology (excluding refractive error), patients with glaucoma, history of eye injury or ophthalmic surgery - No known allergy to contact lens material - Patients undergoing anterior cervical spine surgery and prone spine surgery for duration of 3 hours or longer Exclusion Criteria: - Unable to comply with follow up or give informed consent - Cannot tolerate wearing contact lens - Has active eye infection |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Duchess of Kent Children's Hospital | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong |
Hong Kong,
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. — View Citation
De Smedt S, Mermoud A, Schnyder C. 24-hour intraocular pressure fluctuation monitoring using an ocular telemetry Sensor: tolerability and functionality in healthy subjects. J Glaucoma. 2012 Oct-Nov;21(8):539-44. doi: 10.1097/IJG.0b013e31821dac43. — View Citation
Deniz MN, Erakgün A, Sertöz N, Yilmaz SG, Ates H, Erhan E. The effect of head rotation on intraocular pressure in prone position: a randomized trial. Braz J Anesthesiol. 2013 Mar-Apr;63(2):209-12. doi: 10.1016/j.bjane.2012.03.008. Epub 2013 Aug 13. — View Citation
Leonardi M, Pitchon EM, Bertsch A, Renaud P, Mermoud A. Wireless contact lens sensor for intraocular pressure monitoring: assessment on enucleated pig eyes. Acta Ophthalmol. 2009 Jun;87(4):433-7. doi: 10.1111/j.1755-3768.2008.01404.x. Epub 2008 Nov 12. — View Citation
Mansouri K, Weinreb R. Continuous 24-hour intraocular pressure monitoring for glaucoma--time for a paradigm change. Swiss Med Wkly. 2012 Mar 28;142:w13545. doi: 10.4414/smw.2012.13545. eCollection 2012. Review. — View Citation
Parekh AS, Mansouri K, Weinreb RN, Tafreshi A, Korn BS, Kikkawa DO. Twenty-four-hour intraocular pressure patterns in patients with thyroid eye disease. Clin Exp Ophthalmol. 2015 Mar;43(2):108-14. doi: 10.1111/ceo.12400. Epub 2014 Sep 29. — View Citation
Postoperative Visual Loss Study Group. Risk factors associated with ischemic optic neuropathy after spinal fusion surgery. Anesthesiology. 2012 Jan;116(1):15-24. doi: 10.1097/ALN.0b013e31823d012a. — View Citation
Setogawa A, Kawai. Measurement of intraocular pressure by both invasive and noninvasive techniques in rabbits exposed to head-down tilt. Jpn J Physiol. 1998 Feb;48(1):25-31. — View Citation
Sugata A, Hayashi H, Kawaguchi M, Hasuwa K, Nomura Y, Furuya H. Changes in intraocular pressure during prone spine surgery under propofol and sevoflurane anesthesia. J Neurosurg Anesthesiol. 2012 Apr;24(2):152-6. doi: 10.1097/ANA.0b013e31823fe822. — View 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. — View Citation
Yoshimura K, Hayashi H, Tanaka Y, Nomura Y, Kawaguchi M. Evaluation of predictive factors associated with increased intraocular pressure during prone position spine surgery. J Anesth. 2015 Apr;29(2):170-4. doi: 10.1007/s00540-014-1921-8. Epub 2014 Sep 24. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Report the physiological changes of IOP patterns during prone spinal surgery | The outcome measure will be to report the physiological changes of IOP patterns during prone spinal surgery. | 1 year | |
Secondary | Correlate any intraoperative risk factors that may cause IOP fluctuations | To correlate any intraoperative risk factors that may cause IOP fluctuations | 1 year | |
Secondary | Documentation of IOP changes after the surgery until the contact lens sensor is removed | Documentation of IOP changes after the surgery until the contact lens sensor is removed | 1 year |
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