Glaucoma
Conditions
Brief 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.
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
Interventions
DEVICEMicroPulse 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
Sponsors
Mayo Clinic
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change In IOP | Baseline, 12 months post procedure | Change in intraocular pressure (IOP), reported in millimeters of mercury (mm Hg) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of anti-glaucoma medications | 12 months | Number of anti-glaucoma medication drops |
| Change in visual acuity | Baseline, 12 months post procedure | Change in visual acuity score |
| Change in cup-disc ratio | Baseline, 12 months post procedure | Ratio of the size of the optic cup to the optic disc |
| Change in visual field | Baseline, 12 months post procedure | Total area visible in peripheral vision when focused on a central point, reported in degrees |
| Change in iris color | Baseline, 12 months post procedure | Number of subjects to have a change in their iris color |
| Complications | 12 months | Number of subjects to experience complications from the procedure |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORSyril Dorairaj, MBBS
Mayo Clinic
Outcome results
None listed