NCT03187418

Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Completed NA Results posted Last updated 8 October 2021

What this trial tests

NA trial testing MicroPulse® P3 Glaucoma Device (MP3) in Glaucoma in 52 participants. Completed in 15 February 2020.

Timeline

19 June 2017

Primary endpoint
15 February 2020

15 February 2020

Quick facts

Lead sponsor	Centre hospitalier de l'Université de Montréal (CHUM)
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	52
Start date	19 June 2017
Primary completion	15 February 2020
Estimated completion	15 February 2020
Sites	1 location across Canada

Drugs / interventions tested

• MicroPulse® P3 Glaucoma Device (MP3)

Conditions studied

• Glaucoma — all drugs for Glaucoma →
• Glaucoma, Open-Angle — all drugs for Glaucoma, Open-Angle →
• Glaucoma, Neovascular — all drugs for Glaucoma, Neovascular →
• Glaucoma and Ocular Hypertension — all drugs for Glaucoma and Ocular Hypertension →

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Who can join

18 and older, any sex, with Glaucoma or Glaucoma, Open-Angle. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Intraocular Pressure (IOP) Primary · 18 months

In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

Group	Value	95% CI
Micropulse Trans-scleral CPC	15.2	± 4.1

Intraocular Pressure (IOP) Secondary · 1 week, 1 month, 3 months, 6 months, 12 months

In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

1 week

Group	Value	95% CI
Micropulse Trans-scleral CPC	18.2	± 6.3

1 month

Group	Value	95% CI
Micropulse Trans-scleral CPC	19.2	± 7.4

3 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	18.6	± 6.2

6 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	17.9	± 5.3

12 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	16.7	± 5.6

Number of Participants With Repeat Treatments Secondary · 18 months

Number of participants needing a repeat laser treatment during the study

Group	Value	95% CI
Micropulse Trans-scleral CPC	10

Number of Intraocular Pressure Lowering Medications Secondary · 1 week, 1 month, 3 months, 6 months, 12 months, 18 months

Number of drops and oral medications used by the patient compared to baseline

1 week

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.5	± 0.7

1 month

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.4	± 0.8

3 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.4	± 0.9

6 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.4	± 0.8

12 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.2	± 0.9

18 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	3.2	± 0.9

Corrected Distance Visual Acuity (CDVA) Secondary · 1 week, 1 month, 3 months, 6 months, 12 months, 18 months

Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters

1 week

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.81	± 0.86

1 month

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.84	± 0.90

3 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.79	± 0.88

6 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.77	± 0.86

12 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.79	± 0.86

18 months

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.82	± 0.88

Cup-to-disc Ratio (CDR) Secondary · 18 months

Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.82	± 0.13

Visual Field Index (VFI) Secondary · 18 months

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Group	Value	95% CI
Micropulse Trans-scleral CPC	57	± 27

Mean Deviation (MD) Secondary · 18 months

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Group	Value	95% CI
Micropulse Trans-scleral CPC	-15.16	± 7.72

Pattern Standard Deviation (PSD) Secondary · 18 months

Determined by Humphrey automated perimetry Sita 24-2 visual field testing

Group	Value	95% CI
Micropulse Trans-scleral CPC	7.87	± 3.18

Average Retinal Nerve Fiber Layer (RNFL) Thickness Secondary · 18 months

In micrometer, determined by optical coherence tomography (OCT)

Group	Value	95% CI
Micropulse Trans-scleral CPC	62	± 12

Average Ganglion Cell Layer (GCL) Thickness Secondary · 18 months

In micrometer, determined by optical coherence tomography (OCT)

Group	Value	95% CI
Micropulse Trans-scleral CPC	53	± 14

Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT) Secondary · 18 months

Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters

Group	Value	95% CI
Micropulse Trans-scleral CPC	0.82	± 0.13

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.