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

Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study

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.

Study Overview

• Status: Completed
• Conditions: Glaucoma
• Intervention / Treatment: Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

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

• Study Type: Observational
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Mayo Clinic Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects scheduled for a MP-TSCPC procedure at the Florida Mayo Clinic site.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
240 Second Group; Receives 240 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps	Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device; The MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers; Other Names: MP-TLT
300 Second Group; Receives 300 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 10 sweeps	Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device; The MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers; Other Names: MP-TLT
200 Second Group; Receives 200 seconds total of MicroPulse Transscleral Laser Therapy with the revised P3 Delivery Device delivered in a total of 8 sweeps	Device: MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device; The MicroPulse G-Probe was applied to the superior and inferior hemispheres of the eye under varied treatment times and sweep numbers; Other Names: MP-TLT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change In IOP	Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)	Baseline, 12 months post procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Mayo Clinic
• Investigators: Principal Investigator: Syril Dorairaj, MBBS, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): April 18, 2022
• Primary Completion (Actual): June 30, 2023
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: December 8, 2022
• First Submitted That Met QC Criteria: December 8, 2022
• First Posted (Actual): December 16, 2022

Study Record Updates

• Last Update Posted (Actual): March 19, 2026
• Last Update Submitted That Met QC Criteria: March 16, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 19-008815

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No