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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654493
• Other study ID #: 19-008815
• Status: Recruiting
• Phase: N/A
• Start date: April 18, 2022
• Est. completion date: December 2024

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 65
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change In IOP	Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)	Baseline, 12 months post procedure
Secondary	Number of anti-glaucoma medications	Number of anti-glaucoma medication drops	12 months
Secondary	Change in visual acuity	Change in visual acuity score	Baseline, 12 months post procedure
Secondary	Change in cup-disc ratio	Ratio of the size of the optic cup to the optic disc	Baseline, 12 months post procedure
Secondary	Change in visual field	Total area visible in peripheral vision when focused on a central point, reported in degrees	Baseline, 12 months post procedure
Secondary	Change in iris color	Number of subjects to have a change in their iris color	Baseline, 12 months post procedure
Secondary	Complications	Number of subjects to experience complications from the procedure	12 months