Real-World Effectiveness of Hydrus Microstent and OMNI Surgical System Combined with Phacoemulsification for Open-Angle Glaucoma
Led by Barnet Dulaney Perkins Eye Centers · Updated on 2025-05-01
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
This research aims to evaluate how well the combination of Phacoemulsification, OMNI Canaloplasty, and Hydrus Microstent lowers intraocular pressure IOP in patients with Open Angle Glaucoma. The study focuses on a group of ethnically diverse patients who have undergone this combined surgical procedure. Researchers are analyzing real-world data retrospectively to understand the surgerys effectiveness over time.
The study involves reviewing data from 300 eyes that received the combined treatment of Phacoemulsification with the OMNI Surgical System and Hydrus Microstent. These procedures are performed together to potentially lower IOP in patients with Open Angle Glaucoma. The analysis looks at the impact of this combined surgical approach on IOP reduction over a follow-up period.
Participants are involved through retrospective data collection, including their medication use, eye pressure, and visual field measurements. The main outcome measured is the efficacy of the surgical process combined with Phacoemulsification over 24 months. Additional benefits are also monitored over 36 months. The study ensures thorough follow-up data is available for at least three years, helping researchers assess the long-term impact of the treatment.
CONDITIONS
Brief Title
Efficacy of Surgical Systems in Combination With Phacoemulsification: a Retrospective Analysis
Research Team
D
Derek J Arnson, Master of Education
C
Christine Funke, Medical Doctor
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Subjects with history of the combined Phacoemulsification, OMNI Canaloplasty, and Hydrus microstent surgery with at least 3 years of follow-up data
Diagnosed with glaucoma
Adults aged 18 years or older
You will not qualify if you...
Patients with angle closure glaucoma or secondary glaucoma due to neovascularization, uveitis, congenital glaucoma, or congenital anomalies
Patients with refractory cystoid macular edema lasting 3 months or more after surgery
Patients with incomplete intraocular pressure, medication, or visual field data during the post-operative period
Patients with prior incisional glaucoma surgery or minimally invasive glaucoma surgery (MIGS)
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (retrospective data review)
Surgery and Immediate Post-operative Care
Duration - Single surgical event with immediate post-operative period
Participants underwent combination Phacoemulsification, OMNI Canaloplasty, and Hydrus microstent surgery to lower intraocular pressure (IOP).
Approximately 1 surgical procedure and immediate post-operative assessments
Post-operative Follow-up
Duration - Up to 36 months
Participants are followed up for at least 3 years to monitor the efficacy and safety of the surgical intervention.
Follow-up visits based on routine clinical care during the 3-year period
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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Published Research Related To This Trial
Short-term report of early glaucoma surgery with a clear lens extraction and an intraocular lens, OMNI canaloplasty, and a HYDRUS microstent: a case series in younger patients.
Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.
Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy.