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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
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| 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 |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change In IOP | Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg) | Baseline, 12 months post procedure |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects scheduled for a MP-TSCPC procedure at the Florida Mayo Clinic site.
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| Name | Affiliation | Role |
|---|---|---|
| Syril Dorairaj, MBBS | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic Florida | Jacksonville | Florida | 32224 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| 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 |