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Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis

Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06953349
Enrollment
300
Registered
2025-05-01
Start date
2025-03-31
Completion date
2025-12-31
Last updated
2025-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Open-Angle Glaucoma

Keywords

Hydrus Microstent, OMNI Surgical System, Phacoemulsification

Brief summary

Real-World efficacy of Hydrus Microstent with OMNI Surgical System in combination with Phacoemulsification: a retrospective analysis

Detailed description

The use of combination Phacoemulsification, OMNI Canaloplasty and Hydrus microstent successfully lowers IOP in ethnically-diverse patients with Open Angle Glaucoma

Interventions

PROCEDUREReal-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

Sponsors

Alcon, a Novartis Company
CollaboratorINDUSTRY
Barnet Dulaney Perkins Eye Centers
Lead SponsorNETWORK

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Measured Efficacy of Surgical Process with Phacoemulsification24 monthsPrimary endpoint stratified by complete or qualified success: • Proportion of patients with complete success (%) - without the use of medications

Secondary

MeasureTime frameDescription
Additional Benefits of the Surgical System and Phacoemulsification36 months• Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline

Countries

United States

Contacts

Primary ContactDerek J Arnson, Master of Education
derek.arnson@researchavp.com4804201005
Backup ContactChristine Funke, Medical Doctor
christine.funke@BDPEC.com4804201005

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026