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Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Primary Purpose

Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
MicroPulse® P3 Glaucoma Device (MP3)
Sponsored by
Centre hospitalier de l'Université de Montréal (CHUM)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Cyclophotocoagulation, Micropulse TSCPC, Laser ablation, Laser therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

    1. mild glaucoma: IOP > 18 mmHg
    2. moderate glaucoma: IOP > 15 mmHg
    3. advanced glaucoma: IOP > 12 mmHg
  • Considered poor candidates for additional filtering surgery or implantation of glaucoma drainage devices.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Centre Hospitalier de l'Université de Montréal (CHUM)

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Micropulse trans-scleral CPC

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Intraocular Pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Number of Participants With Repeat Treatments
Number of participants needing a repeat laser treatment during the study
Number of Intraocular Pressure Lowering Medications
Number of drops and oral medications used by the patient compared to baseline
Corrected Distance Visual Acuity (CDVA)
Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters
Cup-to-disc Ratio (CDR)
Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
Visual Field Index (VFI)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Mean Deviation (MD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Pattern Standard Deviation (PSD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Average Retinal Nerve Fiber Layer (RNFL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
Average Ganglion Cell Layer (GCL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
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
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)

Full Information

First Posted
June 12, 2017
Last Updated
September 13, 2021
Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
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1. Study Identification

Unique Protocol Identification Number
NCT03187418
Brief Title
Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma
Official Title
Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation (mTSCPC) in Uncontrolled Glaucoma at the University of Montreal Hospital Center (CHUM)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
June 19, 2017 (Actual)
Primary Completion Date
February 15, 2020 (Actual)
Study Completion Date
February 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular, Glaucoma and Ocular Hypertension, Glaucoma Eye, Glaucoma, Uncompensated, Glaucoma Secondary
Keywords
Cyclophotocoagulation, Micropulse TSCPC, Laser ablation, Laser therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, interventional and monocentric study based in a university hospital setting
Masking
None (Open Label)
Allocation
N/A
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Micropulse trans-scleral CPC
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
MicroPulse® P3 Glaucoma Device (MP3)
Other Intervention Name(s)
CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)
Intervention Description
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).
Primary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Intraocular Pressure (IOP)
Description
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time Frame
1 week, 1 month, 3 months, 6 months, 12 months
Title
Number of Participants With Repeat Treatments
Description
Number of participants needing a repeat laser treatment during the study
Time Frame
18 months
Title
Number of Intraocular Pressure Lowering Medications
Description
Number of drops and oral medications used by the patient compared to baseline
Time Frame
1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Title
Corrected Distance Visual Acuity (CDVA)
Description
Number of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters
Time Frame
1 week, 1 month, 3 months, 6 months, 12 months, 18 months
Title
Cup-to-disc Ratio (CDR)
Description
Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
Time Frame
18 months
Title
Visual Field Index (VFI)
Description
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time Frame
18 months
Title
Mean Deviation (MD)
Description
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time Frame
18 months
Title
Pattern Standard Deviation (PSD)
Description
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time Frame
18 months
Title
Average Retinal Nerve Fiber Layer (RNFL) Thickness
Description
In micrometer, determined by optical coherence tomography (OCT)
Time Frame
18 months
Title
Average Ganglion Cell Layer (GCL) Thickness
Description
In micrometer, determined by optical coherence tomography (OCT)
Time Frame
18 months
Title
Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
Description
Progression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters
Time Frame
18 months
Title
Pain Level During Laser Treatment
Description
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)
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmanjit Singh, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Marchand, MD
Organizational Affiliation
Centre hospitalier de l'Université de Montréal (CHUM)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier de l'Université de Montréal (CHUM)
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2X 3E4
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
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Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

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