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NCT Number: NCT06953349

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

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Key information

Conditions

Open-angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Barnet Dulaney Perkins Eye Center

Mesa, Arizona, 85206, United States

Location status: Recruiting

Location contact

Christine Funke, Medical Doctor

CONTACT

[email protected]

4804201005

Christine Funke, Medical Doctor

PRINCIPAL_INVESTIGATOR

Derek J Arnson, Master of Education

CONTACT

[email protected]

4804201005

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Procedure

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

Other names: OMNI, Hydrus Microstent

Primary outcomes

  1. Measured Efficacy of Surgical Process with Phacoemulsification

    Time frame: 24 months

    Primary endpoint stratified by complete or qualified success:

    • Proportion of patients with complete success (%) - without the use of medications

Secondary outcomes

  1. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Proportion of patients with qualified success (%) - with glaucoma meds without increase from baseline

  2. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Overall IOP reduction from baseline (mmHg)

  3. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Overall medication reduction (#0-5)

  4. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Rate of mean deviation change (dB)

  5. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)

  6. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    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

  7. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Overall medication reduction from baseline, measured at 12, 24 and 36 month timepoints

  8. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Overall IOP reduction from baseline, measured at 12, 24 and 36 month timepoints

  9. Additional Benefits of the Surgical System and Phacoemulsification

    Time frame: 36 months

    • Rate of mean deviation change from baseline to postop time points in Humphrey visual field tests

Study contacts

Contact information is provided by the study sponsor or research team.

Christine Funke, Medical Doctor

CONTACT

[email protected]

4804201005

Derek J Arnson, Master of Education

CONTACT

[email protected]

4804201005

Sponsors and collaborators

Lead sponsor

Barnet Dulaney Perkins Eye Centers

Network

Collaborators

  • Alcon, a Novartis Company

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
May 1, 2025
Registry last updated
May 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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