Treatment Outcomes of MicroPulse Trans-scleral Cyclophotocoagulation in Uncontrolled Glaucoma

NCT03187418 | Completed Results DMC FDA Device

• 1 other identifier: CE16.351
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Intraocular Pressure (IOP)

  In millimeters of mercury (mmHg), measured with the Goldmann applanation tonometer

  18 months

Secondary Outcomes (12)

• Intraocular Pressure (IOP)

  1 week, 1 month, 3 months, 6 months, 12 months

• Number of Participants With Repeat Treatments

  18 months

• Number of Intraocular Pressure Lowering Medications

  1 week, 1 month, 3 months, 6 months, 12 months, 18 months

• Corrected Distance Visual Acuity (CDVA)

  1 week, 1 month, 3 months, 6 months, 12 months, 18 months

• Cup-to-disc Ratio (CDR)

  18 months

Study Arms (1)

Micropulse trans-scleral CPC

EXPERIMENTAL

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)

Interventions

MicroPulse® P3 Glaucoma Device (MP3) DEVICE

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).

Also known as: CYCLO G6 Glaucoma Laser System (Iridex, Mountain View, CA)

Micropulse trans-scleral CPC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2X 3E4, Canada

Location

Related Publications (29)

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• Marchand M, Singh H, Agoumi Y. Micropulse trans-scleral laser therapy outcomes for uncontrolled glaucoma: a prospective 18-month study. Can J Ophthalmol. 2021 Dec;56(6):371-378. doi: 10.1016/j.jcjo.2021.01.015. Epub 2021 Feb 10.

  PMID: 33577756 DERIVED

MeSH Terms

Conditions

Glaucoma; Glaucoma, Open-Angle; Glaucoma, Neovascular; Ocular Hypertension; Glaucoma, Angle-Closure

Condition Hierarchy (Ancestors)

Eye Diseases

Results Point of Contact

• Title: Dr. Michael Marchand, MD
• Organization: Centre Hospitalier de l'Universite de Montreal (CHUM)

michael.marchand-gareau@umontreal.ca

514-890-8000

Study Officials

• Harmanjit Singh, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

• Michael Marchand, MD

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, interventional and monocentric study based in a university hospital setting

Study Record Dates

• First Submitted: June 12, 2017
• First Posted: June 15, 2017
• Study Start: June 19, 2017
• Primary Completion: February 15, 2020
• Study Completion: February 15, 2020
• Last Updated: October 8, 2021
• Results First Posted: October 8, 2021

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)