Intraocular Pressure During Abdominal Aortic Aneurysm (AAA) Repair

NCT00450294 | Completed Results DMC

• 1 other identifier: B2006:180
• Study Type: observational
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Problem With Vision Blindness; Intraocular Pressure; Ischemic Optic Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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.

  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

• Left Intraocular Pressure

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

  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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients with known infrarenal abdominal aortic aneurysm for open repair will be screened through the preadmission anesthetic clinic. If they do not meet exclusion criteria and have signed informed consent for the the study, they will be enrolled to assess for changes in intraocular pressure during open abdominal aortic aneurysm repair.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

St. Boniface General Hospital

Winnipeg, Manitoba, R2H 2A6, Canada

Location

Related Publications (16)

• Roth S, Thisted RA, Erickson JP, Black S, Schreider BD. Eye injuries after nonocular surgery. A study of 60,965 anesthetics from 1988 to 1992. Anesthesiology. 1996 Nov;85(5):1020-7. doi: 10.1097/00000542-199611000-00009.

  PMID: 8916818 BACKGROUND

• Warner ME, Warner MA, Garrity JA, MacKenzie RA, Warner DO. The frequency of perioperative vision loss. Anesth Analg. 2001 Dec;93(6):1417-21, table of contents. doi: 10.1097/00000539-200112000-00013.

  PMID: 11726416 BACKGROUND

• Stevens WR, Glazer PA, Kelley SD, Lietman TM, Bradford DS. Ophthalmic complications after spinal surgery. Spine (Phila Pa 1976). 1997 Jun 15;22(12):1319-24. doi: 10.1097/00007632-199706150-00008.

  PMID: 9201834 BACKGROUND

• Nuttall GA, Garrity JA, Dearani JA, Abel MD, Schroeder DR, Mullany CJ. Risk factors for ischemic optic neuropathy after cardiopulmonary bypass: a matched case/control study. Anesth Analg. 2001 Dec;93(6):1410-6, table of contents. doi: 10.1097/00000539-200112000-00012.

  PMID: 11726415 BACKGROUND

• Lee LA, Roth S, Posner KL, Cheney FW, Caplan RA, Newman NJ, Domino KB. The American Society of Anesthesiologists Postoperative Visual Loss Registry: analysis of 93 spine surgery cases with postoperative visual loss. Anesthesiology. 2006 Oct;105(4):652-9; quiz 867-8. doi: 10.1097/00000542-200610000-00007.

  PMID: 17006060 BACKGROUND

• Brown RH, Schauble JF, Miller NR. Anemia and hypotension as contributors to perioperative loss of vision. Anesthesiology. 1994 Jan;80(1):222-6. doi: 10.1097/00000542-199401000-00033. No abstract available.

  PMID: 8291715 BACKGROUND

• Myers MA, Hamilton SR, Bogosian AJ, Smith CH, Wagner TA. Visual loss as a complication of spine surgery. A review of 37 cases. Spine (Phila Pa 1976). 1997 Jun 15;22(12):1325-9. doi: 10.1097/00007632-199706150-00009.

  PMID: 9201835 BACKGROUND

• Hayreh SS, Jonas JB. Optic disc morphology after arteritic anterior ischemic optic neuropathy. Ophthalmology. 2001 Sep;108(9):1586-94. doi: 10.1016/s0161-6420(01)00649-2.

  PMID: 11535455 BACKGROUND

• Beck RW, Servais GE, Hayreh SS. Anterior ischemic optic neuropathy. IX. Cup-to-disc ratio and its role in pathogenesis. Ophthalmology. 1987 Nov;94(11):1503-8.

  PMID: 3684223 BACKGROUND

• Williams EL, Hart WM Jr, Tempelhoff R. Postoperative ischemic optic neuropathy. Anesth Analg. 1995 May;80(5):1018-29. doi: 10.1097/00000539-199505000-00029. No abstract available.

  PMID: 7726399 BACKGROUND

• Hayreh SS. Anterior ischemic optic neuropathy. Clin Neurosci. 1997;4(5):251-63.

  PMID: 9292252 BACKGROUND

• Cheng MA, Todorov A, Tempelhoff R, McHugh T, Crowder CM, Lauryssen C. The effect of prone positioning on intraocular pressure in anesthetized patients. Anesthesiology. 2001 Dec;95(6):1351-5. doi: 10.1097/00000542-200112000-00012.

  PMID: 11748391 BACKGROUND

• 13 Kayacan N, Gulbin A, Akar M, Karsli B. The effect of pneumoperitoneum and head-down position on intraocular pressure. Gynaecological Endoscopy 2002;11:383-87.

  BACKGROUND

• Larkin DF, Connolly P, Magner JB, Wood AE, Eustace P. Intraocular pressure during cardiopulmonary bypass. Br J Ophthalmol. 1987 Mar;71(3):177-80. doi: 10.1136/bjo.71.3.177.

  PMID: 3828271 BACKGROUND

• Gelman S. The pathophysiology of aortic cross-clamping and unclamping. Anesthesiology. 1995 Apr;82(4):1026-60. doi: 10.1097/00000542-199504000-00027. No abstract available.

  PMID: 7717537 BACKGROUND

• Murphy DF. Anesthesia and intraocular pressure. Anesth Analg. 1985 May;64(5):520-30. No abstract available.

  PMID: 3158256 BACKGROUND

MeSH Terms

Conditions

Optic Neuropathy, Ischemic

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

There were no limitations to trial during course of study.

Results Point of Contact

• Title: Dr. Amit Chopra
• Organization: Department of Anesthesia

amitchopra1@live.com

204-880-5370

Study Officials

• Amit Chopra, M.D.

  University of Manitoba, Department Of Anesthesiology, Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 21, 2007
• First Posted: March 22, 2007
• Study Start: March 1, 2007
• Study Completion: August 1, 2007
• Last Updated: March 31, 2014
• Results First Posted: March 31, 2014

Record last verified: 2014-02

Locations

CA (1)