GlaucomaNCT03187418

Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

A study testing MicroPulse® P3 Glaucoma Device (MP3) in people with Glaucoma and Glaucoma, Open-Angle, run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The goal of this study is to evaluate the efficacy and safety of the novel form of trans-scleral cyclophotocoagulation using micropulse diode laser and trans-pars plana treatment (Micropulse TSCPC, mTSCPC MP3, IRIDEX CYCLO G6™ Glaucoma Laser System, CA, USA) in adults for the treatment of uncontrolled glaucoma. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular
What is being tested?: MicroPulse® P3 Glaucoma Device (MP3)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 52 participants
Where: 1 siteCanada
Study dates: 19 Jun 2017to 15 Feb 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Patients of either sex and any race aged 18 years old and above.
Followed by a glaucoma subspecialist at University of Montreal Hospital Center.
Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.
mild glaucoma: IOP > 18 mmHg
moderate glaucoma: IOP > 15 mmHg
advanced glaucoma: IOP > 12 mmHg
Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.

Who cannot join

Patients unable to give informed consent.
Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
Intraocular surgery in the study eye in the 2 months prior to enrolment.

Trial locations and contacts

1 site in 1 country.

Canada1 site

Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2X 3E4

Other trials in Canada

About this study

Official title: Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation (mTSCPC) in Uncontrolled Glaucoma at the University of Montreal Hospital Center (CHUM)

Read the detailed description

Cyclophotocoagulation (CPC) is a type of cycloablation using laser to treat glaucoma. It involves ciliary body destruction by targeting the ciliary epithelium and stroma, resulting in a reduction in aqueous secretion and hence intraocular pressure. This strategy is effective for all forms of glaucoma.

Traditional trans-scleral cyclophotocoagulation (TSCPC) achieve its cyclodestructive action by using continuous diode laser to target the melanin in the pigmented ciliary body epithelium. However, the continuous mode has been shown to cause significant collateral tissue damage to adjacent non-pigmented structures including the ciliary stroma and ciliary muscle. Traditional TSCPC may therefore be associated with serious complications including uveitis, visual deterioration, chronic hypotony, and others.

More recently, a micropulse delivery mode of diode laser (Micropulse TSCPC, mTSCPC) has been used to treat glaucoma by ablating the ciliary processes and reduce aqueous humor production with more selective targeting and less collateral damage. In contrast to conventional laser delivery where a continuous flow of high intensity energy is delivered, micropulse laser application delivers a series of repetitive short pulses of energy with rest periods in between pulses. Only a few studies have described the outcomes of this novel glaucoma therapy, showing mTSCPC to have comparable efficacy with fewer side effects when compared with traditional continuous wave mode diode laser delivery.This improved side effect profile has the potential to make mTSCPC an earlier therapeutic option instead of reserving it exclusively for end-stage refractory eyes.

Conditions: Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular, Glaucoma and Ocular Hypertension, Glaucoma Eye, Glaucoma, Uncompensated
Being tested: MicroPulse® P3 Glaucoma Device (MP3)
Keywords: Cyclophotocoagulation, Micropulse TSCPC, Laser ablation, Laser therapy
Medical subject headings: Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular, Ocular Hypertension, Glaucoma, Angle-Closure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MicroPulse® P3 Glaucoma Device (MP3)Device
Also called CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)
Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %.
The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus).
The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).

Study groups in NCT03187418
Study group	Role	What they receive
Micropulse trans-scleral CPC	Experimental	A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA). Receives: Device: MicroPulse® P3 Glaucoma Device (MP3)

What is being measured

The primary outcome is the main question the study is designed to answer.

Intraocular Pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Measured: 18 months

Secondary outcomes (12)

Intraocular Pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Measured: 1 week, 1 month, 3 months, 6 months, 12 months
Number of Participants With Repeat Treatments
Number of participants needing a repeat laser treatment during the study
Measured: 18 months
Number of Intraocular Pressure Lowering Medications
Number of drops and oral medications used by the patient compared to baseline
Measured: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Corrected Distance Visual Acuity (CDVA)
Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters
Measured: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Cup-to-disc Ratio (CDR)
Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
Measured: 18 months
Visual Field Index (VFI)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Measured: 18 months
Mean Deviation (MD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Measured: 18 months
Pattern Standard Deviation (PSD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Measured: 18 months
Average Retinal Nerve Fiber Layer (RNFL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
Measured: 18 months
Average Ganglion Cell Layer (GCL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
Measured: 18 months
Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters
Measured: 18 months
Pain Level During Laser Treatment
Using a verbal analog scale for pain level (none = no subjective feeling of pain, mild = pain easily tolerable, moderate = pain tolerable with difficulty, severe = pain intolerable)
Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

19 Jun 201715 Feb 2020

First posted15 Jun 2017
Study start19 Jun 2017
Primary completion15 Feb 2020
Study completion15 Feb 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (29)Papers the sponsor has linked to this study.
Other trials for GlaucomaStudies of the same condition, open and under way.
More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The 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 N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, interventional and monocentric study based in a university hospital setting
Masking: None (open label)
Enrolment: 52 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03187418
Sponsor's protocol ID: CE16.351
Status last verified: Aug 2020
First submitted: 12 Jun 2017
Last updated: 8 Oct 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
PubMed 16488940
Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
PubMed 24974815
Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009 Mar;20(2):122-5. doi: 10.1097/ICU.0b013e32831da828.
PubMed 19240544
Schlote T, Derse M, Rassmann K, Nicaeus T, Dietz K, Thiel HJ. Efficacy and safety of contact transscleral diode laser cyclophotocoagulation for advanced glaucoma. J Glaucoma. 2001 Aug;10(4):294-301. doi: 10.1097/00061198-200108000-00009.
PubMed 11558814
Agarwal HC, Gupta V, Sihota R. Evaluation of contact versus non-contact diode laser cyclophotocoagulation for refractory glaucomas using similar energy settings. Clin Exp Ophthalmol. 2004 Feb;32(1):33-8. doi: 10.1046/j.1442-9071.2004.00754.x.
PubMed 14746588
Schlote T, Derse M, Zierhut M. Transscleral diode laser cyclophotocoagulation for the treatment of refractory glaucoma secondary to inflammatory eye diseases. Br J Ophthalmol. 2000 Sep;84(9):999-1003. doi: 10.1136/bjo.84.9.999.
PubMed 10966953
Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001 Mar;119(3):345-50. doi: 10.1001/archopht.119.3.345.
PubMed 11231767
Leszczynski R, Gierek-Lapinska A, Forminska - Kapuscik M. Transscleral cyclophotocoagulation in the treatment of secondary glaucoma. Med Sci Monit. 2004 Sep;10(9):CR542-8. Epub 2004 Aug 20.
PubMed 15328489
Rotchford AP, Jayasawal R, Madhusudhan S, Ho S, King AJ, Vernon SA. Transscleral diode laser cycloablation in patients with good vision. Br J Ophthalmol. 2010 Sep;94(9):1180-3. doi: 10.1136/bjo.2008.145565. Epub 2010 Jun 24.
PubMed 20576775
Pantcheva MB, Kahook MY, Schuman JS, Rubin MW, Noecker RJ. Comparison of acute structural and histopathological changes of the porcine ciliary processes after endoscopic cyclophotocoagulation and transscleral cyclophotocoagulation. Clin Exp Ophthalmol. 2007 Apr;35(3):270-4. doi: 10.1111/j.1442-9071.2006.01415.x.
PubMed 17430515
Tan AM, Chockalingam M, Aquino MC, Lim ZI, See JL, Chew PT. Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. Clin Exp Ophthalmol. 2010 Apr;38(3):266-72. doi: 10.1111/j.1442-9071.2010.02238.x.
PubMed 20447122
Aquino MC, Barton K, Tan AM, Sng C, Li X, Loon SC, Chew PT. Micropulse versus continuous wave transscleral diode cyclophotocoagulation in refractory glaucoma: a randomized exploratory study. Clin Exp Ophthalmol. 2015 Jan-Feb;43(1):40-6. doi: 10.1111/ceo.12360. Epub 2014 Jun 21.
PubMed 24811050
Bloom PA, Tsai JC, Sharma K, Miller MH, Rice NS, Hitchings RA, Khaw PT. "Cyclodiode". Trans-scleral diode laser cyclophotocoagulation in the treatment of advanced refractory glaucoma. Ophthalmology. 1997 Sep;104(9):1508-19; discussion 1519-20. doi: 10.1016/s0161-6420(97)30109-2.
PubMed 9307649
Kosoko O, Gaasterland DE, Pollack IP, Enger CL. Long-term outcome of initial ciliary ablation with contact diode laser transscleral cyclophotocoagulation for severe glaucoma. The Diode Laser Ciliary Ablation Study Group. Ophthalmology. 1996 Aug;103(8):1294-302. doi: 10.1016/s0161-6420(96)30508-3.
PubMed 8764801
Mistlberger A, Liebmann JM, Tschiderer H, Ritch R, Ruckhofer J, Grabner G. Diode laser transscleral cyclophotocoagulation for refractory glaucoma. J Glaucoma. 2001 Aug;10(4):288-93. doi: 10.1097/00061198-200108000-00008.
PubMed 11558813

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation (mTSCPC) in Uncontrolled Glaucoma at the University of Montreal Hospital Center (CHUM)
ClinicalTrials.gov ID: NCT03187418
Acronym / sponsor ID: CE16.351
Conditions: Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular, Glaucoma and Ocular Hypertension, Glaucoma Eye, Glaucoma, Uncompensated
Keywords: Cyclophotocoagulation, Micropulse TSCPC, Laser ablation, Laser therapy
Study type: Interventional
Recruitment status: Completed
Enrolment: 52 participants (actual)
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
Study start: 19 Jun 2017 (actual)
Primary completion: 15 Feb 2020 (actual)
Study completion: 15 Feb 2020 (actual)
First posted: 15 Jun 2017 (actual)
Results: Posted 8 Oct 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, interventional and monocentric study based in a university hospital setting

Arm	Type	Receives
Micropulse trans-scleral CPC	Experimental	Device: MicroPulse® P3 Glaucoma Device (MP3)A treatment session of micropulse trans-scleral cyclophotocoagulation in the affected eye, using the MicroPulse® P3 Glaucoma Device (MP3) powered by the CYCLO G6™ Glaucoma Laser System (Iridex, Mountain View, CA, USA).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Patients of either sex and any race aged 18 years old and above.
Followed by a glaucoma subspecialist at University of Montreal Hospital Center.
Intraocular pressure (IOP) above target and unresponsive to maximal tolerated medical therapy with or without previous surgical intervention.
Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.

Key exclusion criteria (4 listed)

Patients unable to give informed consent.
Patients with significant scleral thinning, defined as thinning of more than one clock hour noticed on scleral transillumination.
Ocular infection or inflammation in the study eye in the 2 months prior to enrolment.
Intraocular surgery in the study eye in the 2 months prior to enrolment.

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
MicroPulse® P3 Glaucoma Device (MP3)Also: CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)Laser settings will be programmed as follows: power-2000mW-2500mW (average 2000mW) of 810nm infrared diode laser set on micropulse delivery mode; micropulse "on" time-0.5ms; micropulse "off" time-1.1ms; and duty cycle (proportion of each cycle during which the laser is on)-31.33 %. The laser probe will be applied in a continuous sliding or painting motion from 9:30 to 2:30 and from 3:30 to 8:30. The probe will be applied perpendicular to the limbus with the edge directly on the limbus at all times (fiberoptic tip at 3 mm posterior to the limbus). The laser will be delivered over 360° for 160-320s. Treatment duration will be adjusted based on iris color and glaucoma severity (mild glaucoma: 160s, moderate glaucoma: 240s, advanced glaucoma: 240-320s).	Device	Micropulse trans-scleral CPC

Primary outcome

Intraocular Pressure (IOP)
Time frame: 18 months
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

12 secondary outcomes

Intraocular Pressure (IOP)
Time frame: 1 week, 1 month, 3 months, 6 months, 12 months
Number of Participants With Repeat Treatments
Time frame: 18 months
Number of Intraocular Pressure Lowering Medications
Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Corrected Distance Visual Acuity (CDVA)
Time frame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Cup-to-disc Ratio (CDR)
Time frame: 18 months
Visual Field Index (VFI)
Time frame: 18 months
Mean Deviation (MD)
Time frame: 18 months
Pattern Standard Deviation (PSD)
Time frame: 18 months
Average Retinal Nerve Fiber Layer (RNFL) Thickness
Time frame: 18 months
Average Ganglion Cell Layer (GCL) Thickness
Time frame: 18 months
Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
Time frame: 18 months
Pain Level During Laser Treatment
Time frame: 1 day

Results and safety

Results posted to the registry on 8 Oct 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Micropulse Trans-scleral CPC	52	52

Primary outcome: Intraocular Pressure (IOP)

Time frame: 18 months. Mean (Standard Deviation). Unit: millimeters of mercury (mm Hg)

Measure	Micropulse Trans-scleral CPC n = 52
Value	15.2 (4.1)

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 18 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Micropulse Trans-scleral CPC	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16488940Quigley HA, Broman AT. The number of people with glaucoma worldwide in 2010 and 2020. Br J Ophthalmol. 2006 Mar;90(3):262-7. doi: 10.1136/bjo.2005.081224.
Background: PubMed 24974815Tham YC, Li X, Wong TY, Quigley HA, Aung T, Cheng CY. Global prevalence of glaucoma and projections of glaucoma burden through 2040: a systematic review and meta-analysis. Ophthalmology. 2014 Nov;121(11):2081-90. doi: 10.1016/j.ophtha.2014.05.013. Epub 2014 Jun 26.
Background: PubMed 19240544Nguyen QH. Primary surgical management refractory glaucoma: tubes as initial surgery. Curr Opin Ophthalmol. 2009 Mar;20(2):122-5. doi: 10.1097/ICU.0b013e32831da828.
Background: PubMed 11558814Schlote T, Derse M, Rassmann K, Nicaeus T, Dietz K, Thiel HJ. Efficacy and safety of contact transscleral diode laser cyclophotocoagulation for advanced glaucoma. J Glaucoma. 2001 Aug;10(4):294-301. doi: 10.1097/00061198-200108000-00009.
Background: PubMed 14746588Agarwal HC, Gupta V, Sihota R. Evaluation of contact versus non-contact diode laser cyclophotocoagulation for refractory glaucomas using similar energy settings. Clin Exp Ophthalmol. 2004 Feb;32(1):33-8. doi: 10.1046/j.1442-9071.2004.00754.x.
Background: PubMed 10966953Schlote T, Derse M, Zierhut M. Transscleral diode laser cyclophotocoagulation for the treatment of refractory glaucoma secondary to inflammatory eye diseases. Br J Ophthalmol. 2000 Sep;84(9):999-1003. doi: 10.1136/bjo.84.9.999.
Background: PubMed 11231767Egbert PR, Fiadoyor S, Budenz DL, Dadzie P, Byrd S. Diode laser transscleral cyclophotocoagulation as a primary surgical treatment for primary open-angle glaucoma. Arch Ophthalmol. 2001 Mar;119(3):345-50. doi: 10.1001/archopht.119.3.345.
Background: PubMed 15328489Leszczynski R, Gierek-Lapinska A, Forminska - Kapuscik M. Transscleral cyclophotocoagulation in the treatment of secondary glaucoma. Med Sci Monit. 2004 Sep;10(9):CR542-8. Epub 2004 Aug 20.
Background: PubMed 20576775Rotchford AP, Jayasawal R, Madhusudhan S, Ho S, King AJ, Vernon SA. Transscleral diode laser cycloablation in patients with good vision. Br J Ophthalmol. 2010 Sep;94(9):1180-3. doi: 10.1136/bjo.2008.145565. Epub 2010 Jun 24.
Background: PubMed 17430515Pantcheva MB, Kahook MY, Schuman JS, Rubin MW, Noecker RJ. Comparison of acute structural and histopathological changes of the porcine ciliary processes after endoscopic cyclophotocoagulation and transscleral cyclophotocoagulation. Clin Exp Ophthalmol. 2007 Apr;35(3):270-4. doi: 10.1111/j.1442-9071.2006.01415.x.
Background: PubMed 20447122Tan AM, Chockalingam M, Aquino MC, Lim ZI, See JL, Chew PT. Micropulse transscleral diode laser cyclophotocoagulation in the treatment of refractory glaucoma. Clin Exp Ophthalmol. 2010 Apr;38(3):266-72. doi: 10.1111/j.1442-9071.2010.02238.x.
Background: PubMed 24811050Aquino MC, Barton K, Tan AM, Sng C, Li X, Loon SC, Chew PT. Micropulse versus continuous wave transscleral diode cyclophotocoagulation in refractory glaucoma: a randomized exploratory study. Clin Exp Ophthalmol. 2015 Jan-Feb;43(1):40-6. doi: 10.1111/ceo.12360. Epub 2014 Jun 21.
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.

Harmanjit Singh, MD principal investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Michael Marchand, MD principal investigator

Centre hospitalier de l'Université de Montréal (CHUM)

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MicroPulse® P3 Glaucoma Device (MP3) in people with Glaucoma and Glaucoma, Open-Angle, run by Centre hospitalier de l'Université de Montréal (CHUM) 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 7 inclusion and 4 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 8 Oct 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Oct 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Intraocular Pressure (IOP) (time frame: 18 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03187418, which also lists 29 linked publications.

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 8 Oct 2021.