Clinical trial · Interventional
Preoperative Brimonidine on IOP of Patients Undergoing RALP
A Prospective Study to Evaluate the Effect of Preoperative Topical Brimonidine Tartrate 0.2% (Allergan, Irvine, CA) on Intraocular Pressure (IOP) of Patients Undergoing Robot-assisted Laparoscopic Prostatectomy (RALP)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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 hypotensive agents to reduce IOP. Given the challenges with some of the above options, this study aims to evaluate the effect of pre-operative treatment with topical Brimonidine Tartrate 0.2% on the IOP of patients undergoing RALP with sTBURG. The goal is to prevent the anticipated IOP spike thereby reducing risk of postoperative vision loss.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| brimonidine tartrate 0.2% | Drug | — | UNRESOLVED |
| Carboxymethylcellulose Eye Drops | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Brimonidine Tartrate 0.2% (2mg/mL)
- description
- One (I) drop of brimonidine tartrate 0.2% (2mg/mL) will be placed in the randomized eye preoperatively thirty minutes before robotic-assisted radical laparoscopic prostatectomy (RALP)
- interventionNames
- Drug: brimonidine tartrate 0.2%
- type
- PLACEBO_COMPARATOR
- label
- Carboxymethylcellulose Eye Drops
- description
- One drop of Carboxymethylcellulose eye drops will be placed in the randomized eye half an hour before RALP
- interventionNames
- Other: Carboxymethylcellulose Eye Drops
Primary outcomes (1)
- measure
- Changes in IOP during the course of the surgical procedure between eyes treated with medication and those with placebo with patients undergoing RALP with sTBURG
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Males aged 18 years and above * Patients with a diagnosis of prostatic carcinoma requiring prostate surgery Exclusion Criteria: * Patients having had an ophthalmic surgical procedure within 6 months of the beginning of the study. * Patients with a diagnosis of glaucoma * Any abnormality of the cornea which may prevent reliable applanation tonometry * Known allergy/ hypersensitivity reaction to Brimonidine * Contra-indication to Brimonidine including patients on monoamine oxidase inhibitors (MOA) * Patients unwilling or unable to provide informed consent * Patients with anticipated difficult airway management (as this may require medications and/or airway manipulations resulting in increased IOP)
References
Publications (0)
Data not yet available