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

April 29, 2025 updated by: Barnet Dulaney Perkins Eye Centers

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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 (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Mesa, Arizona, United States, 85206
        • Recruiting
        • Barnet Dulaney Perkins Eye Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christine Funke, Medical Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

300 subjects that have undergone CEIOL/OMNI/Hydrus

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Procedure: 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
Other Names:
  • Hydrus Microstent
  • OMNI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time Frame: 36 months
• Overall IOP reduction from baseline (mmHg)
36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time Frame: 36 months
• Overall medication reduction (#0-5)
36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time Frame: 36 months
• Rate of mean deviation change (dB)
36 months
Additional Benefits of the Surgical System and Phacoemulsification
Time Frame: 36 months
• SSIs (% on trabeculectomy, glaucoma drainage implant (GDI), other)
36 months
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
36 months
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
36 months
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
36 months
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
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Barnet Dulaney Perkins Eye Centers

Collaborators

Alcon, a Novartis Company

Investigators

  • Principal Investigator: Christine Funke, Medical Doctor, Barnet Dulaney Perkins Eye Centers

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 31, 2025

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

April 29, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 29, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Alcon - IIT Proposal 95537309

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

To report on surgical success after cataract surgery in ethnically diverse (Caucasian, Asian, African American, Hispanic, Tribal) patients with multiple glaucoma using combined MIGS procedures.

IPD Sharing Time Frame

IPD will be made available once the study data collection is complete tentatively 12/2025 for a period of 12 months, to tentatively 12/2026

IPD Sharing Access Criteria

The investigators will allow fellow researchers access to the data as the investigators work to publish the findings.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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