Open Angle Glaucoma Clinical Trial
Official title:
Impact of Topical, Retrobulbar and General Anesthesia in Ocular Blood Flow
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.
1. Ultrasound B-mode scans will be performed before and after the anesthetic procedure
2. Doppler scan will be added to the B-mode ultrasound to register the blood flow pattern
of the ophthalmic and central retinal arteries
3. Blood pressure and heart rate will be monitored
;
Time Perspective: Prospective
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT03284853 -
Safety and Efficacy Study of PG324 (Netarsudil/Latanoprost 0.02% / 0.005%) Ophthalmic Solution Compared to GANFORT® Ophthalmic Solution in Open Angle Glaucoma or Ocular Hypertension
|
Phase 3 | |
Terminated |
NCT03611530 -
CoQun Study - (COQUN): a Study to Evaluate the Effects of CoQun in Patients Affected by Open-angle Glaucoma
|
N/A | |
Not yet recruiting |
NCT06441643 -
Next Generation Rocklatan
|
Phase 2 | |
Not yet recruiting |
NCT02868502 -
Different Glaucoma Treatments Effect on Intraocular Pressure Fluctuation With Postural Change in Eyes With Open-angle Glaucoma
|
N/A | |
Completed |
NCT02628223 -
180 Degree vs. 360 Degree Selective Laser Trabeculoplasty as Initial Therapy for Glaucoma
|
N/A | |
Completed |
NCT02272569 -
STARflo European Safety and Efficacy Study
|
N/A | |
Completed |
NCT01936389 -
A Prospective Study to Assess the Hypotensive Efficacy of Rho-Kinase Inhibitor AR-12286 Ophthalmic Solution 0.5% and 0.7% in Patients With Exfoliation Syndrome and Ocular Hypertension or Glaucoma
|
Phase 2 | |
Completed |
NCT00941525 -
Central Corneal Thickness and 24-hour Fluctuation of Intraocular Pressure
|
Phase 4 | |
Completed |
NCT00539526 -
Evaluation of Hyperemia With the Use of Ocular Prostaglandin Analogues
|
Phase 4 | |
Completed |
NCT00121147 -
Additivity Study: Additive Effect on Eye Pressure of Azopt and Alphagan P to Travatan
|
N/A | |
Active, not recruiting |
NCT05035394 -
Swedish Microinvasive Glaucoma Surgery Study (SMIGS)
|
N/A | |
Completed |
NCT03450629 -
Evaluation of Safety and Efficacy of PDP-716
|
Phase 3 | |
Active, not recruiting |
NCT06061718 -
Travoprost Intraocular Implant in Conjunction With Cataract Surgery
|
Phase 3 | |
Recruiting |
NCT05241938 -
PSLT Compared to Prostaglandin Analogue Eye Drops
|
N/A | |
Completed |
NCT01342406 -
Effects of Selective Laser Trabeculoplasty on Aqueous Humor Dynamics
|
||
Completed |
NCT02250612 -
SYL040012, Treatment for Open Angle Glaucoma
|
Phase 2 | |
Completed |
NCT01937312 -
Effect of SIMBRINZA® Suspension as an Added Therapy to a Prostaglandin Analogue
|
Phase 4 | |
Terminated |
NCT01983579 -
TF (SENSIMED Triggerfish) in Intraocular Anti-VEGF (Vascular Endothelial Growth Factor) Injection
|
Phase 4 | |
Completed |
NCT01937299 -
Effect of SIMBRINZA® Suspension as an Added Therapy to TRAVATAN Z®
|
Phase 4 | |
Completed |
NCT01229982 -
A Study Evaluating the Latanoprost Punctal Plug Delivery System (L-PPDS) in Subjects With Ocular Hypertension or Open-Angle Glaucoma
|
Phase 2 |