Preoperative Brimonidine on IOP of Patients Undergoing RALP (IOPsTBURG)

September 25, 2018 updated by: University Health Network, Toronto

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)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

With completed informed consent, study participants will undergo a pre-operative comprehensive ophthalmic evaluation to document best corrected visual acuity (VA), IOP measurements, visual field assessments (VF), optical coherence tomography measurements (OCT) of the retinal nerve fiber layer, optic disc photography and screening for other ophthalmologic abnormalities. Height and weight measurements will also be recorded.

Using opaque envelopes with the aid of Sequentially Numbered Opaque Sealed Envelopes (SNOSE) schemes, each patient will be randomized to either right eye or left eye. Thereafter patients will be randomized to placebo (carboxymethylcellulose) or drop (Brimonidine tartrate 0.2%) which will be given 30 minutes before the start of surgery with the patient in horizontal supine position. Eyes randomized to receive a drop will be treated with one drop of Brimonidine tartrate 0.2% while eyes randomized to receive placebo will receive one drop of Carboxymethylcellulose eye drops (Control group).

IOP measurements will be recorded for both eyes pre-operatively in the upright seated position (baseline), pre-anaesthetized in supine horizontal position, intra-operatively in anaesthetized supine horizontal position, hourly intra-operatively in anaesthetized sTBURG, awake post-operatively in supine horizontal position and at 1 month postoperatively in the upright seated position. Three IOP measurements will be recorded, each with 5% confidence interval (CI). Blood pressure and end tidal carbon dioxide will be recorded hourly intra-operatively. The following surgical data will also be recorded: procedure duration, angle of inclination of surgical bed, anesthetic agents used, fluid volume given, transfusions given, blood loss volume and complications. Best corrected VA, IOP, VF, OCT and optic disc photography will also be recorded for each patient at the 1-month post-operative visit.

Study Type

Interventional

Enrollment (Actual)

26

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Toronto, Canada
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Brimonidine Tartrate 0.2% (2mg/mL)
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%
Alpha adrenergic receptor agonist
Other Names:
  • Alphagan, Allergan, Irvine, CA
PLACEBO_COMPARATOR: Carboxymethylcellulose Eye Drops
One drop of Carboxymethylcellulose eye drops will be placed in the randomized eye half an hour before RALP
Other: Carboxymethylcellulose Eye Drops
Ocular lubricants
Other Names:
  • Refresh Optive Fusion
  • Tear drops

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Visual acuity, visual fields, retinal nerve fiber layer thickness
Time Frame: Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months
Changes in Visual acuity, visual fields, retinal nerve fiber layer thickness when preoperative and postopertive evaluations are compared
Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Buys M Yvonne, MD FRCSC, University of Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 29, 2016

Primary Completion (ACTUAL)

January 24, 2017

Study Completion (ACTUAL)

August 7, 2017

Study Registration Dates

First Submitted

June 22, 2016

First Submitted That Met QC Criteria

June 27, 2016

First Posted (ESTIMATE)

June 30, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 27, 2018

Last Update Submitted That Met QC Criteria

September 25, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 15-9684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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