Prostate CancerPhase 4IOPsTBURGNCT02818816
Preoperative Brimonidine on IOP of Patients Undergoing RALP
A Phase 4 study testing brimonidine tartrate 0.2% and Carboxymethylcellulose Eye Drops in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- brimonidine tartrate 0.2% and Carboxymethylcellulose Eye Drops
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- 29 Feb 2016to 7 Aug 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males aged 18 years and above
- Patients with a diagnosis of prostatic carcinoma requiring prostate surgery
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- brimonidine tartrate 0.2%, Carboxymethylcellulose Eye Drops
- Keywords
- Brimonidine tartrate, Intraocular pressure, Prostate Cancer, Prostatectomy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brimonidine tartrate 0.2%Drug
Also called Alphagan, Allergan, Irvine, CA
Alpha adrenergic receptor agonist
Carboxymethylcellulose Eye DropsOther
Also called Refresh Optive Fusion, Tear drops
Ocular lubricants
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Other: Carboxymethylcellulose Eye Drops |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Changes in Visual acuity, visual fields, retinal nerve fiber layer thickness when preoperative and postopertive evaluations are compared
Measured: Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2016 (estimated)
- Study start29 Feb 2016
- Primary completion24 Jan 2017
- Study completion7 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Buys M Yvonne, MD FRCSC, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02818816
- Sponsor's protocol ID
- 15-9684
- Acronym
- IOPsTBURG
- Status last verified
- Sep 2018
- First submitted
- 22 Jun 2016
- Last updated
- 27 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT02818816
- Acronym / sponsor ID
- IOPsTBURG / 15-9684
- Conditions
- Prostate Cancer
- Keywords
- Brimonidine tartrate, Intraocular pressure, Prostate Cancer, Prostatectomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- 29 Feb 2016 (actual)
- Primary completion
- 24 Jan 2017 (actual)
- Study completion
- 7 Aug 2017 (actual)
- First posted
- 30 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brimonidine Tartrate 0.2% (2mg/mL) | Experimental | Drug: brimonidine tartrate 0.2%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) |
| Carboxymethylcellulose Eye Drops | Placebo comparator | Other: Carboxymethylcellulose Eye DropsOne drop of Carboxymethylcellulose eye drops will be placed in the randomized eye half an hour before RALP |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Males aged 18 years and above
- Patients with a diagnosis of prostatic carcinoma requiring prostate surgery
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| brimonidine tartrate 0.2%Also: Alphagan, Allergan, Irvine, CAAlpha adrenergic receptor agonist | Drug | Brimonidine Tartrate 0.2% (2mg/mL) |
| Carboxymethylcellulose Eye DropsAlso: Refresh Optive Fusion, Tear dropsOcular lubricants | Other | Carboxymethylcellulose Eye Drops |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Buys M Yvonne, MD FRCSC principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing brimonidine tartrate 0.2% and Carboxymethylcellulose Eye Drops in people with Prostate Cancer, run by University Health Network, Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: Preoperatively within 1-2 months, intraoperatively, and postoperatively within 1-2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2018.