N/A
N=10
Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair
Problem With Vision Blindness · Intraocular Pressure · Ischemic Optic Neuropathy
Bottom Line
View on ClinicalTrials.gov: NCT00450294 ↗Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. — 16.9; 13.8; 14.6; 13.5 mm Hg — p=<0.001
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- —
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Manitoba
- Primary completion
- —
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery. |
16.9; 13.8; 14.6; 13.5; 14.1; 14.4 | <0.001 sig |
| PRIMARY Left Intraocular Pressure |
16.7; 15; 14.7; 13.7; 14.6; 15.1 | <0.001 sig |
Summary
The objective of this study will be to answer a clinical question that has not already been investigated; that is, what are the effects of aortic infra-renal clamping and unclamping on intraocular pressure during Abdominal Aortic Aneurysm (AAA) repair? Depending on the results, this study may raise or alleviate concern that vascular surgery for abdominal aortic aneurysm could contribute to early perioperative exacerbation of pre-existing eye disease and increase a patient's vulnerability to developing a type of blindness known as ischemic optic neuropathy. The purpose of this observational study is to evaluate whether intraocular pressure measurements with a handheld tonometer will detect changes in intraocular pressure related to intraoperative events during aortic cross clamping and unclamping that may provide information on causes of perioperative blindness.
Eligibility Criteria
Inclusion Criteria
- All patients presenting to St. Boniface General Hospital for elective AAA repair requiring an arterial line, central line and general anesthesia will be eligible for inclusion in this study.
Exclusion Criteria
- . The exclusion criteria for this study are:
- Patients with a history of acute or chronic eye disease
- Allergy to topical ophthalmologic anesthesia
- Patients receiving nitrous oxide, ketamine or succinylcholine during anesthesia
- If the surgical procedure will require the aorta to be re-clamped following unclamping, those patients will also be excluded
- Patients that are VRE+ or MRSA+ will be excluded for infection control purposes
Data sourced from ClinicalTrials.gov (NCT00450294). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.