Trial Outcomes & Findings for Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma (NCT NCT03187418)
NCT ID: NCT03187418
Last Updated: 2021-10-08
Results Overview
In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
52 participants
Primary outcome timeframe
18 months
Results posted on
2021-10-08
Participant Flow
Participant milestones
| Measure |
Micropulse Trans-scleral CPC
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Overall Study
STARTED
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52
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|
Overall Study
COMPLETED
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52
|
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma
Baseline characteristics by cohort
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Age, Continuous
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69 years
STANDARD_DEVIATION 14 • n=5 Participants
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Sex: Female, Male
Female
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26 Participants
n=5 Participants
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Sex: Female, Male
Male
|
26 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
41 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
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6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Middle East
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3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
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Region of Enrollment
Canada
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52 participants
n=5 Participants
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Glaucoma diagnosis
Primary open angle glaucoma
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28 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Neovascular glaucoma
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5 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Pseudoexfoliative glaucoma
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4 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Congenital/infantile glaucoma
|
4 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Chronic primary angle-closure glaucoma
|
3 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Pigmentary glaucoma
|
3 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Other secondary glaucoma
|
2 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Uveitic/inflammatory glaucoma
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1 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Combined mechanism glaucoma
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1 Participants
n=5 Participants
|
|
Glaucoma diagnosis
Normotensive glaucoma
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1 Participants
n=5 Participants
|
|
Glaucoma severity
Mild
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1 Participants
n=5 Participants
|
|
Glaucoma severity
Moderate
|
16 Participants
n=5 Participants
|
|
Glaucoma severity
Advanced
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35 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsIn millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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Intraocular Pressure (IOP)
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15.2 millimeters of mercury (mm Hg)
Standard Deviation 4.1
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SECONDARY outcome
Timeframe: 1 week, 1 month, 3 months, 6 months, 12 monthsIn millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Intraocular Pressure (IOP)
1 week
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18.2 millimeters of mercury (mm Hg)
Standard Deviation 6.3
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Intraocular Pressure (IOP)
1 month
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19.2 millimeters of mercury (mm Hg)
Standard Deviation 7.4
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|
Intraocular Pressure (IOP)
3 months
|
18.6 millimeters of mercury (mm Hg)
Standard Deviation 6.2
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Intraocular Pressure (IOP)
6 months
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17.9 millimeters of mercury (mm Hg)
Standard Deviation 5.3
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Intraocular Pressure (IOP)
12 months
|
16.7 millimeters of mercury (mm Hg)
Standard Deviation 5.6
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SECONDARY outcome
Timeframe: 18 monthsNumber of participants needing a repeat laser treatment during the study
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Number of Participants With Repeat Treatments
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10 Participants
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SECONDARY outcome
Timeframe: 1 week, 1 month, 3 months, 6 months, 12 months, 18 monthsNumber of drops and oral medications used by the patient compared to baseline
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Number of Intraocular Pressure Lowering Medications
18 months
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3.2 glaucoma medication classes
Standard Deviation 0.9
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|
Number of Intraocular Pressure Lowering Medications
1 month
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3.4 glaucoma medication classes
Standard Deviation 0.8
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Number of Intraocular Pressure Lowering Medications
1 week
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3.5 glaucoma medication classes
Standard Deviation 0.7
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Number of Intraocular Pressure Lowering Medications
3 months
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3.4 glaucoma medication classes
Standard Deviation 0.9
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Number of Intraocular Pressure Lowering Medications
6 months
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3.4 glaucoma medication classes
Standard Deviation 0.8
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Number of Intraocular Pressure Lowering Medications
12 months
|
3.2 glaucoma medication classes
Standard Deviation 0.9
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SECONDARY outcome
Timeframe: 1 week, 1 month, 3 months, 6 months, 12 months, 18 monthsNumber of lines reduction or improvement from baseline on Snellen acuity chart at 6 meters
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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Corrected Distance Visual Acuity (CDVA)
1 week
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0.81 LogMAR
Standard Deviation 0.86
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Corrected Distance Visual Acuity (CDVA)
1 month
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0.84 LogMAR
Standard Deviation 0.90
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Corrected Distance Visual Acuity (CDVA)
3 months
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0.79 LogMAR
Standard Deviation 0.88
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Corrected Distance Visual Acuity (CDVA)
6 months
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0.77 LogMAR
Standard Deviation 0.86
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Corrected Distance Visual Acuity (CDVA)
12 months
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0.79 LogMAR
Standard Deviation 0.86
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Corrected Distance Visual Acuity (CDVA)
18 months
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0.82 LogMAR
Standard Deviation 0.88
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SECONDARY outcome
Timeframe: 18 monthsProgression of CDR compared to baseline, assessed by an ophthalmologist on dilated fundus examination
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Cup-to-disc Ratio (CDR)
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0.82 ratio
Standard Deviation 0.13
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SECONDARY outcome
Timeframe: 18 monthsDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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Visual Field Index (VFI)
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57 percents
Standard Deviation 27
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SECONDARY outcome
Timeframe: 18 monthsDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Mean Deviation (MD)
|
-15.16 decibel (dB)
Standard Deviation 7.72
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SECONDARY outcome
Timeframe: 18 monthsDetermined by Humphrey automated perimetry Sita 24-2 visual field testing
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Pattern Standard Deviation (PSD)
|
7.87 decibel (dB)
Standard Deviation 3.18
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SECONDARY outcome
Timeframe: 18 monthsIn micrometer, determined by optical coherence tomography (OCT)
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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Average Retinal Nerve Fiber Layer (RNFL) Thickness
|
62 micrometers
Standard Deviation 12
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SECONDARY outcome
Timeframe: 18 monthsIn micrometer, determined by optical coherence tomography (OCT)
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Average Ganglion Cell Layer (GCL) Thickness
|
53 micrometers
Standard Deviation 14
|
SECONDARY outcome
Timeframe: 18 monthsProgression of vertical CDR compared to baseline, assessed by optical coherence tomography (OCT) parameters
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Cup-to-disc Ratio (CDR) Assessed by Optical Coherence Tomography (OCT)
|
0.82 ratio
Standard Deviation 0.13
|
SECONDARY outcome
Timeframe: 1 dayUsing 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)
Outcome measures
| Measure |
Micropulse Trans-scleral CPC
n=52 Participants
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).
MicroPulse® P3 Glaucoma Device (MP3): 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).
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|---|---|
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Pain Level During Laser Treatment
None
|
34 Participants
|
|
Pain Level During Laser Treatment
Mild
|
12 Participants
|
|
Pain Level During Laser Treatment
Moderate
|
6 Participants
|
|
Pain Level During Laser Treatment
Severe
|
0 Participants
|
Adverse Events
Micropulse Trans-scleral CPC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Michael Marchand, MD
Centre Hospitalier de l'Universite de Montreal (CHUM)
Phone: 514-890-8000
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place