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OpenTrials
Completed

NCT Number: NCT05654493

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MicroPulse Transscleral Laser Therapy using revised P3 Delivery Device

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

Primary outcomes

  1. Change In IOP

    Time frame: Baseline, 12 months post procedure

    Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)

Secondary outcomes

  1. Number of anti-glaucoma medications

    Time frame: 12 months

    Number of anti-glaucoma medication drops

  2. Change in visual acuity

    Time frame: Baseline, 12 months post procedure

    Change in visual acuity score

  3. Change in cup-disc ratio

    Time frame: Baseline, 12 months post procedure

    Ratio of the size of the optic cup to the optic disc

  4. Change in visual field

    Time frame: Baseline, 12 months post procedure

    Total area visible in peripheral vision when focused on a central point, reported in degrees

  5. Change in iris color

    Time frame: Baseline, 12 months post procedure

    Number of subjects to have a change in their iris color

  6. Complications

    Time frame: 12 months

    Number of subjects to experience complications from the procedure

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2022
Registry last updated
Mar 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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