Recruiting

Surgical Systems

Sponsor:

Barnet Dulaney Perkins Eye Centers

Code:

NCT06953349

Conditions

Open-Angle Glaucoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

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

Study Details

Brief summary:

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

Conditions

Open-Angle Glaucoma

Study ID

NCT06953349

Start date

Mar 31, 2025

Status verified date

Mar, 2025

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Nov 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

300 participants

Anticipated

Interventions and Outcome Measures

Arms

Single Group/Cohort retrospectively utilized

This will be 300 eyes that have undergone the combination of Phacoemulsification, OMNI Canaloplasty and Hydrus microstent that will successfully lower IOP in ethnically-diverse patients with Open Angle Glaucoma

Interventions

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

Primary outcome measure

  • Measured Efficacy of Surgical Process with Phacoemulsification [ Time Frame: 24 months ]

Central Contacts and Locations

Central contacts

Derek J Arnson, Master of Education

4804201005derek.arnson@researchavp.com

Christine Funke, Medical Doctor

4804201005christine.funke@BDPEC.com

Locations

Barnet Dulaney Perkins Eye Center

Recruiting

Mesa, Arizona, United States, 85206

Contacts

Derek J Arnson, Master of Education

4804201005derek.arnson@researchavp.com

Christine Funke, Medical Doctor

4804201005christine.funke@BDPEC.com

Principal Investigator:

Christine Funke, Medical Doctor

More Information

Sponsor

Barnet Dulaney Perkins Eye Centers

Last update posted

May 1, 2025

Last verified

Mar, 2025

Keywords

  • Hydrus Microstent
  • OMNI Surgical System
  • Phacoemulsification

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Barnet Dulaney Perkins Eye Centers on 2025-05-01.