Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

Centre hospitalier de l'Université de Montréal (CHUM)

Status: Completed

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

Treatments: Device: MicroPulse® P3 Glaucoma Device (MP3)

Study type: Interventional

Funder types: Other

Identifiers

NCT03187418

CE16.351

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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52 participants in 1 patient group

Micropulse trans-scleral CPC

Experimental group

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).

Treatment:

Device: MicroPulse® P3 Glaucoma Device (MP3)