Clinical trial NCT03187418: 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
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Glaucoma, Open-Angle
Glaucoma, Neovascular
Glaucoma and Ocular Hypertension
Glaucoma Eye
Glaucoma, Uncompensated
Glaucoma Secondary
Keywords: Cyclophotocoagulation
Micropulse TSCPC
Laser ablation
Laser therapy
Lead sponsor: Centre hospitalier de l'Université de Montréal (CHUM)
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, interventional and monocentric study based in a university hospital setting
Primary purpose: TREATMENT

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.

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.

  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.

Primary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 18 months
Secondary outcomes:
measure: Intraocular Pressure (IOP)
timeFrame: 1 week, 1 month, 3 months, 6 months, 12 months
measure: Number of Participants With Repeat Treatments
timeFrame: 18 months
measure: Number of Intraocular Pressure Lowering Medications
timeFrame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
measure: Corrected Distance Visual Acuity (CDVA)
timeFrame: 1 week, 1 month, 3 months, 6 months, 12 months, 18 months
measure: Cup-to-disc Ratio (CDR)
timeFrame: 18 months
measure: Visual Field Index (VFI)
timeFrame: 18 months
measure: Mean Deviation (MD)
timeFrame: 18 months
measure: Pattern Standard Deviation (PSD)
timeFrame: 18 months
measure: Average Retinal Nerve Fiber Layer (RNFL) Thickness
timeFrame: 18 months
measure: Average Ganglion Cell Layer (GCL) Thickness
timeFrame: 18 months
measure: Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
timeFrame: 18 months
measure: Pain Level During Laser Treatment
timeFrame: 1 day
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Centre Hospitalier de l'Université de Montréal (CHUM)
state: Quebec
Study officials:
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Harmanjit Singh, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre hospitalier de l'Université de Montréal (CHUM)
name: Michael Marchand, MD
role: PRINCIPAL_INVESTIGATOR
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