Mayo Clinic Florida
Jacksonville, Florida, 32224, United States
NCT Number: NCT05654493
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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Notify Me18 year and older
All sexes
Observational
Jacksonville, Florida, 32224, United States
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
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: Baseline, 12 months post procedure
Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg)
Time frame: 12 months
Number of anti-glaucoma medication drops
Time frame: Baseline, 12 months post procedure
Change in visual acuity score
Time frame: Baseline, 12 months post procedure
Ratio of the size of the optic cup to the optic disc
Time frame: Baseline, 12 months post procedure
Total area visible in peripheral vision when focused on a central point, reported in degrees
Time frame: Baseline, 12 months post procedure
Number of subjects to have a change in their iris color
Time frame: 12 months
Number of subjects to experience complications from the procedure
Mayo Clinic
Other
Use of Micropulse Trans-Scleral Cyclophotocoagulation Laser (MP-TSCPC) for Glaucoma Patients: Clinical Outcomes. Prospective Observational Cohort Study
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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