Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Glaucoma, Glaucoma, Open-Angle, Glaucoma, Neovascular, Glaucoma and Ocular Hypertension, Glaucoma Eye, Glaucoma, Uncompensated, Glaucoma Secondary

Intervention / Treatment
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* Device: MicroPulse® P3 Glaucoma Device (MP3)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, interventional and monocentric study based in a university hospital setting
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Micropulse trans-scleral CPC<br>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). | Device: MicroPulse® P3 Glaucoma Device (MP3)<br>* 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).<br>* Other names: CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) | In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer | 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 | 18 months | 
| Number of Intraocular Pressure Lowering Medications | Number of drops and oral medications used by the patient compared to baseline | 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 | 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 | 18 months | 
| Visual Field Index (VFI) | Determined by Humphrey automated perimetry Sita 24-2 visual field testing | 18 months | 
| Mean Deviation (MD) | Determined by Humphrey automated perimetry Sita 24-2 visual field testing | 18 months | 
| Pattern Standard Deviation (PSD) | Determined by Humphrey automated perimetry Sita 24-2 visual field testing | 18 months | 
| Average Retinal Nerve Fiber Layer (RNFL) Thickness | In micrometer, determined by optical coherence tomography (OCT) | 18 months | 
| Average Ganglion Cell Layer (GCL) Thickness | In micrometer, determined by optical coherence tomography (OCT) | 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 | 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) | 1 day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cyclophotocoagulation, Micropulse TSCPC, Laser ablation, Laser therapy