Working…
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Continuous Intraocular Pressure Patterns in Spine Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03299400
Recruitment Status : Completed
First Posted : October 3, 2017
Last Update Posted : October 4, 2017
Sponsor:
Information provided by (Responsible Party):
Dr. Kenny Kwan, The University of Hong Kong

Tracking Information
First Submitted Date  ICMJE September 27, 2017
First Posted Date  ICMJE October 3, 2017
Last Update Posted Date October 4, 2017
Actual Study Start Date  ICMJE May 9, 2016
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
Report the physiological changes of IOP patterns during prone spinal surgery [ Time Frame: 1 year ]
The outcome measure will be to report the physiological changes of IOP patterns during prone spinal surgery.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2017)
  • Correlate any intraoperative risk factors that may cause IOP fluctuations [ Time Frame: 1 year ]
    To correlate any intraoperative risk factors that may cause IOP fluctuations
  • Documentation of IOP changes after the surgery until the contact lens sensor is removed [ Time Frame: 1 year ]
    Documentation of IOP changes after the surgery until the contact lens sensor is removed
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Continuous Intraocular Pressure Patterns in Spine Surgery
Official Title  ICMJE Continuous Intraocular Pressure Patterns in Spine Surgery
Brief Summary

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.

Detailed Description

Post-operative visual loss (POVL) is a rare but serious complication after surgery.

One of the known associations is prone spinal surgery with a prolonged duration.

The cause is not completely understood, but some of the risk factors for developing POVL include anaemia, hypotension, the duration of surgery and patient factors such as age, hypertension and atherosclerosis. There are also some unidentifiablerisk factors that may predispose young healthy patients to POVL. Once the patient develops POVL, it is usually irreversible, and the patient is left with a permanent disability.

The majority of POVL cases that occur with prone spinal surgery are due to posterior ischaemic optic neuropathy (PION). PION 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.

However, there is a knowledge gap in the physiological changes of IOP during prone surgery. IOP is a highly dynamic parameter, and the most widely used method to measure it is using a handheld tonometer. The main limitation of this technique is the isolated nature of its measurements, as it can only be taken at regular intervals, and may not reflect the full range of IOP changes. Studies on IOP during prone position in the current literature have all used this technique. 1-5 Hence subtle changes of IOP can be undetected, as interval measurements cannot reflect short-term variations that occur within seconds or minutes. Furthermore, most of the studies are performed on animals or healthy volunteers 5,6 , which further limit the interpretation of their results. For the few studies performed on anaesthetised patients undergoing spinal surgeries, the duration of surgery is short or mixed, so the critical time point may not have been studied. The American Society of Anesthesiologists Postoperative Visual Loss Registry suggests that an anaesthetic duration of greater than 6 hours is more correlated with POVL.

Using state of the art technology Over the past five years, advances in technology have led to the development of devices that allow 24 hour continuous IOP monitoring. The new system makes use of microelectromechanical systems, nanotechnology, and telemetry to allow continuous monitoring. A disposable contact lens sensor, first proposed by Leonardi et al. 8 , is now commercially available (SENSIMED Triggerfish; Sensimed AG, Lausanne, Switzerland). This technology can acquire data points over a 24 hour period corresponding to 30 seconds of continuous measurements. It measures changes in the ocular dimensions at the corneoscleral junction, which corresponds to changes to IOP and volume. The microprocessor within the lens transmits data to an external antenna, and the profiles can be stored in a portable recorder. 9 Although this sensor does not measure IOP directly, it gives measurements with a composite of IOP and volume changes, and it is most valuable in documenting relative changes of IOP-related events and their timing. It is also well tolerated in real life patients, and have been used to document IOP changes in patients with glaucoma and thyroid eye disease. 9-11 This is the only non-invasive temporary continuous monitoring in the system that can be used in human beings. This new technology is therefore ideal in detecting subtle changes in IOP pattern in prone spinal surgery. It will provide a continuous monitoring which can be correlated with the patient's level of anaesthesia, arterial pressure fluctuations and volume status, and can contribute to improved understanding of IOP changes during prone spinal surgery, which may in turn bridge the knowledge gap of the causes of POVL.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Intervention Model Description:

All eligible patients who have given informed consent will attend the ophthalmology clinic for screening.

Patient will undergo general anaesthesia for prone spinal surgery. The degree of inclination was set prior to the start of the case and independently confirmed using a goniometer. Patients will be placed in the prone position on a Jackson Spine table.

Once positioned, the head is carefully placed on the GentleTouch prone positioning pillow of the appropriate size.

Patient will continue to wear the contact lens postoperatively for a total of 24 hours or until the patient cannot tolerate the contact lens. After removal of the contact lens sensor, the recorded profiles will be collected and visualized graphically on a computer interface. The output of the sensor expressed in voltage, and can be analysed in real time points corresponding to the intraoperative events.

Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Intraocular Pressure
Intervention  ICMJE Device: Contact lens sensor
Patient will continue to wear the contact lens postoperatively for a total of 24 hours or until the patient cannot tolerate the contact lens. After removal of the contact lens sensor, the recorded profiles will be collected and visualized graphically on a computer interface.
Study Arms  ICMJE Experimental: Contact lens sensor
Patient will continue to wear the contact lens postoperatively for a total of 24 hours or until the patient cannot tolerate the contact lens. After removal of the contact lens sensor, the recorded profiles will be collected and visualized graphically on a computer interface.
Intervention: Device: Contact lens sensor
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 27, 2017)
10
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 9, 2017
Actual Primary Completion Date May 9, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hong Kong
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03299400
Other Study ID Numbers  ICMJE UW 16-207
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Dr. Kenny Kwan, The University of Hong Kong
Study Sponsor  ICMJE The University of Hong Kong
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr Kenny Kwan, BMBCh(Oxon) The University of Hong Kong
PRS Account The University of Hong Kong
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP