About this trial
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with h/o CEIOL/OMNI/Hydrus (chosen based on subjects on more than 1 medication pre-operatively) with at least 3 years of follow up data
have Glaucoma
Disqualifiers
Patients with angle closure glaucoma or secondary forms of glaucoma due to neovascularization of the angle, uveitic glaucoma, congenital glaucoma, or glaucoma due to congenital anomalies.
Patients with refractory CME or CME persisting 3 months or more post-operatively
Patients with incomplete IOP, medication logs or VF data within post-operative period
Prior incisional surgery or MIGS
Trial population
300 subjects that have undergone CEIOL/OMNI/Hydrus
Trial design
Other
Retrospective
Treatments tested in this trial
Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis
Procedure/SurgeryThe use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma
Treatment groups
Trial outcomes
Primary outcomes
Measured 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
Secondary outcomes
Additional Benefits of the Surgical System and Phacoemulsification
• Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline
Additional Benefits of the Surgical System and Phacoemulsification
• Overall IOP reduction from baseline (mmHg)
Additional Benefits of the Surgical System and Phacoemulsification
• Overall medication reduction (#0-5)
Additional Benefits of the Surgical System and Phacoemulsification
• Rate of mean deviation change (dB)
Sponsors and contacts
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Barnet Dulaney Perkins Eye Centers
Lead sponsor
Alcon, a Novartis Company
Collaborator