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

Not Applicable

Recruiting

• Conditions: Glaucoma
• Interventions: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

• Registration Number: NCT05654493
• Lead Sponsor: Mayo Clinic

Brief Summary

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.

Detailed 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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2022-04-18
• Study First Submitted: 2022-12-08
• Study First Submitted QC: 2022-12-08
• Study First Posted: 2022-12-16
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-28
• Last Update Posted: 2024-04-01
• Primary Completion: 2024-12
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
240 Second Group	MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device	Receives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps
300 Second Group	MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device	Receives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps
200 Second Group	MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device	Receives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps

Primary Outcome Measures

Name	Time	Method
Change In IOP	Baseline, 12 months post procedure	Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)

Secondary Outcome Measures

Name	Time	Method
Number of anti-glaucoma medications	12 months	Number of anti-glaucoma medication drops
Complications	12 months	Number of subjects to experience complications from the procedure
Change in cup-disc ratio	Baseline, 12 months post procedure	Ratio of the size of the optic cup to the optic disc
Change in visual field	Baseline, 12 months post procedure	Total area visible in peripheral vision when focused on a central point, reported in degrees
Change in visual acuity	Baseline, 12 months post procedure	Change in visual acuity score
Change in iris color	Baseline, 12 months post procedure	Number of subjects to have a change in their iris color

Trial Locations

Locations (1)

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States