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Intraoperative Ocular Pressure in Lumbar Spine Fusion Patients

NCT02342288 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 79

Last updated 2016-02-24

Study results available
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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.

Conditions

  • Raised Ocular Pressure

Interventions

PROCEDURE

Head raised 10 degrees

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.

PROCEDURE

Head in neutral position

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.

Sponsors & Collaborators

  • West Virginia University

    lead OTHER

Principal Investigators

  • Sanford E Emery, MD, MBA · West Virginia University

Study Design

Allocation
RANDOMIZED
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-07-31
Primary Completion
2014-02-28
Completion
2014-02-28

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02342288 on ClinicalTrials.gov