Preoperative Brimonidine on IOP of Patients Undergoing RALP

NCT02818816 | Completed Phase 4

• 1 other identifier: 15-9684
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

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

Prostate Cancer

Keywords

Brimonidine tartrate; Intraocular pressure; Prostate Cancer; Prostatectomy

Outcome Measures

Primary Outcomes (1)

• 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

  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

  Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months

Secondary Outcomes (1)

• Changes in Visual acuity, visual fields, retinal nerve fiber layer thickness

  Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months

Study Arms (2)

Brimonidine Tartrate 0.2% (2mg/mL)

EXPERIMENTAL

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)

Drug: brimonidine tartrate 0.2%

Carboxymethylcellulose Eye Drops

PLACEBO COMPARATOR

One drop of Carboxymethylcellulose eye drops will be placed in the randomized eye half an hour before RALP

Other: Carboxymethylcellulose Eye Drops

Interventions

brimonidine tartrate 0.2% DRUG

Alpha adrenergic receptor agonist

Also known as: Alphagan, Allergan, Irvine, CA

Brimonidine Tartrate 0.2% (2mg/mL)

Carboxymethylcellulose Eye Drops OTHER

Ocular lubricants

Also known as: Refresh Optive Fusion, Tear drops

Carboxymethylcellulose Eye Drops

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males aged 18 years and above
• Patients with a diagnosis of prostatic carcinoma requiring prostate surgery

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Canada

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Brimonidine Tartrate; Lubricant Eye Drops

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Quinoxalines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Ophthalmic Solutions; Pharmaceutical Solutions; Solutions; Pharmaceutical Preparations; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Lubricants; Specialty Uses of Chemicals

Study Officials

• Buys M Yvonne, MD FRCSC

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2016
• First Posted: June 30, 2016
• Study Start: February 29, 2016
• Primary Completion: January 24, 2017
• Study Completion: August 7, 2017
• Last Updated: September 27, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)