Study on the Impact of Ocular Anesthetic Procedures in Ocular Blood Flow

Tracking Information
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; (submitted: April 22, 2013)	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.
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.
Detailed Description	Ultrasound B-mode scans will be performed before and after the anesthetic procedure; Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern of the ophthalmic and central retinal arteries; Blood pressure and heart rate will be monitored
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	Controls Patients scheduled for elective ophthalmic surgery with no family history of glaucoma, an increased or asymmetrical cup/disc ratio or any other optic disc structural change (notching, disc hemorrhage) or an intraocular pressure (IOP) above 21 mmHg that could suggest possible glaucoma suspects.; Primary open-angle Glaucoma Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at least one measurement of IOP of >21 mmHg required; Normal Tension Glaucoma Patients scheduled for an elective glaucoma surgery that present with a characteristic optic disc damage (based on cup/disc ratio, thinning of neuroretinal rim, notching, disk hemorrhages, etc.) and visual field defects, with at maximum recorded IOP of < 21 mmHg.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: May 28, 2015)	240
Original Estimated Enrollment; (submitted: April 22, 2013)	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: individuals over 18 years old; willing to sign an informed consent and able to comply with the requirements of the study Exclusion Criteria: history of ocular trauma; previous extraocular surgery; ocular disease other than the one motivating surgery; systemic diseases with ocular involvement like diabetes or Graves Ophthalmopathy
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Older Adult)
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	Principal Investigator: Ingeborg Stalmans, MD, PhD UZ Leuven
PRS Account	Universitaire Ziekenhuizen Leuven
Verification Date	February 2013