Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
Study Type
OBSERVATIONAL
Enrollment
300
The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States
RECRUITINGMeasured Efficacy of Surgical Process with Phacoemulsification
Primary endpoint stratified by complete or qualified success: • Proportion of patients with complete success (%) - without the use of medications
Time frame: 24 months
Additional Benefits of the Surgical System and Phacoemulsification
• Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Overall IOP reduction from baseline (mmHg)
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Overall medication reduction (#0-5)
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Rate of mean deviation change (dB)
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
Additional Secondary Endpoint stratified by Complete or Qualified surgical success defined by the following: * Complete success: Without the use of glaucoma medications * Qualified success: Using glaucoma medications, but without an increase from the baseline number
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Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Overall medication reduction from baseline, measured at 12, 24 and 36 month timepoints
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Overall IOP reduction from baseline, measured at 12, 24 and 36 month timepoints
Time frame: 36 months
Additional Benefits of the Surgical System and Phacoemulsification
• Rate of mean deviation change from baseline to postop time points in Humphrey visual field tests
Time frame: 36 months