Finished
Preoperative Brimonidine on IOP of Patients Undergoing RALP
NCT02818816 · University Health Network, Toronto · Updated 27 Sept 2018
- What is being tested
- brimonidine tartrate 0.2%; Carboxymethylcellulose Eye Drops
- For
- Prostate Cancer
- Kind of study
- Tests a treatment or device on volunteers. Phase 4.
- Who can join
- Ages 18 years and older. About 26 people. The full rules are on the registry page.
- Where
- Canada
- When
- Starts or started 29 Feb 2016, ends 7 Aug 2017. Registered 30 June 2016.
- Results
- None posted yet.
In the researchers' words
Patients with prostate cancer undergoing robot assisted radical laparoscopic prostatectomy (RALP) in steep Trendelenburg position (sTBURG) are noted to have elevated intraocular pressures (IOP) intraoperatively. One study showed an increase in IOP of 13 millimeters of mercury (mmHg) from baseline IOP levels intraoperatively. Other studies have shown the IOP to more than double intraoperatively during RALP in sTBURG. IOP is found to be directly related to angle of inclination and increases time dependently with sTBURG. The IOP may remain significantly elevated until the first postoperative day after RALP. There are no previously published data concerning the safe threshold for IOP elevation and the effects of this increased IOP on vision and on generalized eye health are still not entirely known. One study showed postoperative visual field defects in 28% (7/25) of patients who underwent RALP in sTBURG. It has been theorized that sTBURG and subsequent increased IOP are risk factors for postoperative vision loss (PVL). It is believed that the increased IOP decreases optic nerve perfusion pressure causing ischemic optic neuropathy. Some previously recommended ways to reduce the intraoperative IOP spike during RALP include shorter operating times, decreased angle of inclination, modified Trendelenburg position, use of Propofol for maintenance anaesthesia and intraoperative topical…
Sites
- Princess Margaret Cancer CentreToronto, Canada
