Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow
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ClinicalTrials.gov Identifier: NCT01840215 |
Recruitment Status
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Completed
First Posted
: April 25, 2013
Last Update Posted
: May 29, 2015
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Tracking Information | ||||
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First Submitted Date | April 17, 2013 | |||
First Posted Date | April 25, 2013 | |||
Last Update Posted Date | May 29, 2015 | |||
Study Start Date | February 2013 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
Ocular blood flow change [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 2 hours ] The investigators will test whether anesthetic procedures in ophthalmic surgery (topical, retrobulbar and general anesthesia) induce a change in retrobulbar blood flow. The difference in ocular blood flow velocities between pre and post anesthetic induction will be performed.
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Original Primary Outcome Measures | Same as current | |||
Change History | Complete list of historical versions of study NCT01840215 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures | Not Provided | |||
Original Secondary Outcome Measures | Not Provided | |||
Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow | |||
Official Title | Impact of Topical, Retrobulbar and General Anesthesia in Ocular Blood Flow | |||
Brief Summary | Anaesthetic procedures in ophthalmology surgery have been a subject rapidly evolving in the past decades. When deciding for a retrobulbar block, the local injection of varying mixtures and volumes of fast-acting anesthetics (such as lidocaine) - with or without a vasoconstrictive agent (such as adrenaline) - coupled with Hyaluronidase have been the standard care to provide painless surgery while minimizing the possible risks such as increased intraocular pressure (IOP), brainstem anesthesia, toxic reaction and ocular blood flow changes. These iatrogenic-induced vascular dysfunctions have been also suggested to play a role in intra-operatory vision loss (a "wipe-out" phenomenon) in patients with advanced glaucoma. The rationale for the use of epinephrine in retrobulbar anesthesia is to slow absorption of the anesthetic in general circulation and thus to achieve a longer effect in the orbit. However, studies on ocular blood flow after adrenaline-containing compounds have consistently showed a decrease in ocular blood flow, thus raising the issue of whether it should be used in patients with known vascular dysfunction, namely glaucoma patients. Nevertheless, there has been no study to verify this claim concerning the safety of non-adrenaline containing anesthetics. Injecting a pre-determined volume of anesthetic compound behind the globe, regardless of its formulation has also been debated. The orbital pressure increase can lead to a number of adverse reactions, not only increasing IOP but also potentially decreasing vascular input by local compression. In glaucoma for instance, there has been suggested optic nerve sheaths to be less elastic than in healthy individuals, potentially making this structure less compliant to outside compression. These more rigid orbital tissues could also impair the orbit's ability to deal with the iatrogenic increased volume. As seen, the current concepts on the impact of ocular anesthesiology in the orbit and the vascular supply to the eye are limited to a small number of non-homogeneous studies. We aim to study this impact through a non-invasive, widely established ultrasound based method of ocular blood flow research (color Doppler Imaging). Potentially, our study could help determine a taylor-made choice of the anesthesiology procedure to apply to a specific patient, thereby advancing the current standard of care in ophthalmology. |
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Detailed Description |
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Study Type | Observational | |||
Study Design | Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | primary care setting | |||
Condition | Open Angle Glaucoma | |||
Intervention | Not Provided | |||
Study Groups/Cohorts |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
240 | |||
Original Estimated Enrollment |
120 | |||
Actual Study Completion Date | December 2014 | |||
Actual Primary Completion Date | December 2014 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Belgium | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT01840215 | |||
Other Study ID Numbers | S16022013 | |||
Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Universitaire Ziekenhuizen Leuven | |||
Study Sponsor | Universitaire Ziekenhuizen Leuven | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Universitaire Ziekenhuizen Leuven | |||
Verification Date | February 2013 |