Five-Year Visual Field Outcomes of the HORIZON Trial.
Giovanni Montesano, Giovanni Ometto, Iqbal Ike K Ahmed...
https://pubmed.ncbi.nlm.nih.gov/36813144Actively Recruiting
Age: 18Years +
All Genders
ID06953349
Real-World Efficacy of Hydrus Microstent With OMNI Surgical System in Combination With Phacoemulsification: a Retrospective Analysis
Led by Barnet Dulaney Perkins Eye Centers · Updated on 2025-05-01
300
Participants Needed
1
Research Sites
4 weeks
Total Duration
On this page
Sponsors
B
Barnet Dulaney Perkins Eye Centers
Lead Sponsor
A
Alcon, a Novartis Company
Collaborating Sponsor
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 surgery's 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
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- 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)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Barnet Dulaney Perkins Eye Center
Mesa, Arizona, United States, 85206
Actively Recruiting
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Research Team
D
Derek J Arnson, Master of Education
C
Christine Funke, Medical Doctor
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
Canaloplasty and trabeculotomy ab interno with the OMNI system combined with cataract surgery in open-angle glaucoma: 12-month outcomes from the ROMEO study.
Louis Hirsch, Jeremy Cotliar, Steven Vold...
https://pubmed.ncbi.nlm.nih.gov/33315733Visual outcomes of combined cataract surgery and minimally invasive glaucoma surgery.
Steven R Sarkisian, Nathan Radcliffe, Paul Harasymowycz...
https://pubmed.ncbi.nlm.nih.gov/32657904Short-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.
Daniel Laroche, Abelard Desrosiers, Chester Ng
https://pubmed.ncbi.nlm.nih.gov/38983083Hydrus Microstent implantation with OMNI Surgical System Ab interno canaloplasty for the management of open-angle glaucoma in phakic patients refractory to medical therapy.
Jack Creagmile, Won I Kim, Christian Scouarnec
https://pubmed.ncbi.nlm.nih.gov/36544749