Skip to content

Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair

The Effect of Aortic Infrarenal Clamping and Unclamping On Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00450294
Enrollment
10
Registered
2007-03-22
Start date
2007-03-31
Completion date
2007-08-31
Last updated
2014-03-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intraocular Pressure, Ischemic Optic Neuropathy, Problem With Vision Blindness

Brief 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.

Detailed description

Perioperative blindness in nonocular surgery has gained significant clinical interest as an overwhelming complication with an increasing incidence. Initial published studies suggested a rare occurrence with an estimated postoperative visual loss of 0.002% and 0.0008% (1,2). However, retrospective reviews in spinal and cardiac surgery demonstrated higher rates of perioperative blindness; that is, between 0.2% and 0.06% respectively (3,4). The difference in published reports suggests that the true incidence is likely underestimated because of fears regarding litigation, ineffective means of reporting and extra work involved. Fortunately, numerous case reports and series in the middle to late 1990s were published; prompting the American Society of Anesthesiologists (ASA) Committee on Professional Liability to establish the ASA Postoperative Visual Loss Registry (POVL) in 1999 as a medium to collect confidential, comprehensive perioperative data on patients developing postoperative blindness. The POVL registry, along with other case series, has demonstrated that the most common cause of visual loss is non-arteritic ischemic optic neuropathy (5,6,7). Perioperative non-arteritic ischemic optic neuropathy (ION) is a consequence of patient and surgery specific factors that results from hypoperfusion and infarction of the optic nerve head (8). Anatomical factors such as variation in the number of short posterior ciliary arteries (sPCA) supplying the optic nerve head, location of sPCA watershed zone, and small optic cup to disk ratio increase susceptibility to optic nerve ischemia (8,9). Surgery specific factors involve profound blood loss, anemia, hypotension, prone positioning and duration of surgery (5,6,7,10). The interaction of these surgical variables and patient specific anatomical factors can decrease ocular perfusion pressure (the difference between mean arterial pressure and intraocular pressure) and result in ION (11). Based on the determinants of ocular perfusion pressure (OPP), low mean arterial pressure (MAP) and/or high intraocular pressure (IOP) can decrease OPP and lead to ION. Therefore, it is necessary to investigate changes in IOP incurred from different types of surgery that may increase vulnerability to developing ION. Normal IOP is between 12 - 20 mm Hg. Studies have been published assessing intraocular changes with prone positioning, laparoscopic surgery and cardiopulmonary bypass (12,13,14). However, there has been no literature evaluating intraocular pressure during abdominal aortic aneurysm (AAA) repair. AAA repair is a high-risk surgery associated with blood loss, hypotension and has been reported in a case series associated with ION (6). The surgery involves clamping and unclamping of the aorta to facilitate excision of the aneurysm and graft repair. Aortic cross clamping and unclamping is an intense physiologic insult affecting venous return, systemic vascular resistance, cardiac output, and acid base status. These physiologic changes are further pronounced with more proximal cross-clamping and longer duration. Because infrarenal abdominal aortic aneurysms are the most common type of AAA repair, we will be assessing IOP with patients undergoing elective infrarenal abdominal aortic reconstruction. Infrarenal aortic cross clamping is associated with increases in venous return, central venous pressure and arterial blood pressure (15). The hemodynamic changes with infrarenal unclamping entail decreases in venous return, central venous pressure and arterial blood pressure (15). The determinants of intraocular pressure involve extraocular muscle tone, aqueous flow, choroidal blood volume and central venous pressure (16). The volume redistribution proximal to the aortic cross-clamp should cause a rise in venous pressure, increase resistance to aqueous drainage and increase choroidal blood volume thereby increasing intraocular pressure. However, after aortic unclamping, choroidal blood volume and IOP should decrease as venous return and central venous pressure decline. Therefore, our hypothesis is that IOP will be increased during aortic cross clamping and decreased following aortic unclamping.

Interventions

None listed

Sponsors

University of Manitoba
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closureIntraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.
Left Intraocular PressureMeasurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closureIntraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

Countries

Canada

Participant flow

Recruitment details

Ten patients were recruited into the study after informed consent at the preoperative anesthetic clinic during a twelve month period.

Pre-assignment details

Because this is a purely OBSERVATIONAL STUDY, there was no group assignment. All patients enrolled in the study were assigned to one group, that is, all patients had intraocular pressure measurements performed.

Participants by arm

ArmCount
Longitudinal Group
This study is an observational longitudinal design. Ten patients were enrolled to determine what happens to eye pressure during surgery for abdominal aortic aneurysm repair. Therefore, all ten patients had intraocular pressure measurements made at different event intervals to determine if there was a change in intraocular pressure compared to their baseline intraocular pressure that was taken before surgery. No active intervention was performed to the patients based on intraocular pressure as clinicians were blinded to the intraocular pressure values.
10
Total10

Baseline characteristics

CharacteristicLongitudinal Group
Abdominal Aortic Aneurysm Size5.7 cm
STANDARD_DEVIATION 0.5
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
7 Participants
Age, Categorical
Between 18 and 65 years
3 Participants
Age, Continuous68.5 years
STANDARD_DEVIATION 11.2
ASA Physical Status
AASA III (Severe systemic disease)
10 participants
ASA Physical Status
ASA I (healthy person)
0 participants
ASA Physical Status
ASA II (mild systemic disease)
0 participants
ASA Physical Status
ASA IV (Severe systemic disease, constant threat)
0 participants
ASA Physical Status
ASA V (moribund person)
0 participants
Body mass index27.3 kg/m2
STANDARD_DEVIATION 3.4
Cerebrovascular Accident (CVA)
HAS CVA
4 participants
Cerebrovascular Accident (CVA)
No CVA
6 participants
Cross Clamp Duration58 min
STANDARD_DEVIATION 15.3
Cumulative Crystalloid2.84 L
STANDARD_DEVIATION 0.13
Diabetes mellitus
HAS DM
10 participants
Diabetes mellitus
NO DM
0 participants
Epidural
Epidural
10 participants
Epidural
NO Epidural
0 participants
Hyperlipidemia
HAS Hyperlipidemia
10 participants
Hyperlipidemia
NO Hyperlipidemia
0 participants
Hypertension
HAS HTN
10 participants
Hypertension
NO HTN
0 participants
Mannitol
N) Mannitol
0 participants
Mannitol
Received Mannitol
10 participants
Preop Left Intraocular Pressure16.7 mm HG
STANDARD_DEVIATION 2.7
Preop Right Intraocular Pressure16.9 mm Hg
STANDARD_DEVIATION 2.6
Region of Enrollment
Canada
10 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
10 Participants
Vasopressor infusion
NO vasopressor infusion
0 participants
Vasopressor infusion
Vasopressor Infusion
10 participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
— / —
other
Total, other adverse events
0 / 10
serious
Total, serious adverse events
0 / 10

Outcome results

Primary

Left Intraocular Pressure

Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

Time frame: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Longitudinal GroupLeft Intraocular PressurePreoperative16.7 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular PressurePre-incision15 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular Pressure1 min post clamp14.7 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular Pressure5 min post clamp13.7 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular Pressure1 min before unclamp14.6 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular Pressure1 min following unclamp15.1 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular Pressure5 min following unclamp15.3 mm HgStandard Error 0.57
Longitudinal GroupLeft Intraocular PressureSkin closure14.7 mm HgStandard Error 0.57
Comparison: Repeated measures anova with post hoc t-tests using tukey's correction.p-value: <0.001ANOVA
Primary

Right Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.

Intraocular pressure measurements were made with a tonometer. These measurements were recorded and kept blinded from the clinicians.

Time frame: Measurements made at baseline, post induction preincision, 1 min post clamp, 5 min post clamp, 1 min pre unclamp, 1 min post unclamp, 5 min post unclamp, skin closure

Population: The analysis was per protocol.

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.Preoperative16.9 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.Pre-induction13.8 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.1 min post clamp14.6 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.5 min post clamp13.5 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.1 min before unclamp14.1 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.1 min following unclamp14.4 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.5 min following unclamp15 mm HgStandard Error 0.75
Longitudinal GroupRight Intraocular Pressure During Various Event Intervals in Open Abdominal Aortic Aneurysm Surgery.Skin closure14.1 mm HgStandard Error 0.75
Comparison: Repeated measures anova with post hoc t-tests using tukey's correction.p-value: <0.001ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026