Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients

Mayo Clinic

Status: Active, not recruiting

Conditions: Glaucoma

Treatments: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

Study type: Interventional

Funder types: Other

Identifiers

NCT05654493

19-008815

Details and patient eligibility

About

The purpose of this study is to evaluate the clinical outcomes of the Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) after 1 day, 1 week,1 month, 3 months, 6 months and one year of follow-up, with the intent to evaluate the efficacy of using MP-TSCPC to treat glaucoma patients.

Full description

Patients will be submitted to MP-TSCPC throughout the year of 2020, according to parameters determined by the Principal Investigator and executed by the Principal Investigator, after signing the Consent Form and agreeing on having their data used for research purpose. Postsurgical follow up visits will be scheduled for 1 month, 3 months, 6 months and 12 months. Patients IOP, number of medications, visual acuity, visual field, iris color, retinal nerve fiber layer thickness on OCT and any complications (iritis, corneal edema, hyphema, vitreous hemorrhage, vision loss, cataract progression or hypotony maculopathy) will be measured by trained ophthalmic assistants supervised by the Principal Investigator and documented at each visit. Authorized Mayo Clinic personnel will perform chart reviews; using administrative data as designated by Dr. Dorairaj. The data will be statistically analyzed to illustrate the results and determine if the objectives and primary and secondary endpoints were achieved

Enrollment: 65 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnose of glaucoma
• Indication to be submitted to the procedure

Exclusion criteria

• Significant thinning of the sclera
• Current eye infection or inflammation
• Intraocular surgery performed less than 2 months prior to the enrollment in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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65 participants in 3 patient groups

240 Second Group

Experimental group

Description:

Receives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps

Treatment:

Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

300 Second Group

Experimental group

Description:

Receives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps

Treatment:

Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

200 Second Group

Experimental group

Description:

Receives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps

Treatment:

Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device