Evaluating the effectiveness of surgical systems for treating open-angle glaucoma
Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis
This study looks at how well a combination of surgical treatments can lower eye pressure in people with open-angle glaucoma over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Barnet Dulaney Perkins Eye Centers Research network |
| Locations | 1 site (Mesa, Arizona) |
| Trial ID | NCT06953349 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the real-world efficacy of the Hydrus Microstent combined with the OMNI Surgical System and Phacoemulsification in patients with open-angle glaucoma. It focuses on patients who have undergone these procedures and have at least three years of follow-up data. The study aims to assess how well this combination treatment lowers intraocular pressure (IOP) in a diverse patient population. By utilizing retrospective data, the study seeks to provide insights into the long-term outcomes of these surgical interventions.
Who should consider this trial
Good fit: Ideal candidates include patients with a history of cataract surgery and those who have been on multiple medications for glaucoma prior to surgery.
Not a fit: Patients with angle closure glaucoma, secondary glaucoma, or those who have had prior incisional surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment options for patients with open-angle glaucoma, potentially enhancing their quality of life.
How similar studies have performed: Other studies have shown promising results with similar surgical approaches, indicating potential for success in this analysis.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Mesa, Arizona
- Barnet Dulaney Perkins Eye Center — Mesa, Arizona, United States (Recruiting)
Study contacts
- Principal investigator: Christine Funke, Medical Doctor — Barnet Dulaney Perkins Eye Centers
- Study coordinator: Derek J Arnson, Master of Education
- Email: derek.arnson@researchavp.com
- Phone: 4804201005
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.