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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
52
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).
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada
Intraocular Pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time frame: 18 months
Intraocular Pressure (IOP)
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Time frame: 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
Time frame: 18 months
Number of Intraocular Pressure Lowering Medications
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
Corrected Distance Visual Acuity (CDVA)
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
Cup-to-disc Ratio (CDR)
Progression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
Time frame: 18 months
Visual Field Index (VFI)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time frame: 18 months
Mean Deviation (MD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time frame: 18 months
Pattern Standard Deviation (PSD)
Determined by Humphrey automated perimetry Sita 24-2 visual field testing
Time frame: 18 months
Average Retinal Nerve Fiber Layer (RNFL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
Time frame: 18 months
Average Ganglion Cell Layer (GCL) Thickness
In micrometer, determined by optical coherence tomography (OCT)
Time frame: 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
Time frame: 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)
Time frame: 1 day
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