Actively Recruiting
Long-term Follow-up of Hydrus Implant With Phacoemulsification for Lowering Eye Pressure in Glaucoma Patients
Led by Johannes Gutenberg University Mainz · Updated on 2026-03-10
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research investigates the long-term effectiveness and safety of the Hydrus implant combined with phacoemulsification surgery to lower intraocular pressure (IOP) in patients with glaucoma. Glaucoma patients often face high IOP, which requires ongoing control to prevent vision loss and blindness. This study aims to provide the longest follow-up data available, tracking patients for 8 to 14 years post-implantation to understand the lasting impact of the Hydrus implant on eye pressure, medication use, surgical interventions, safety, and quality of life. Participants in this study previously underwent either the combined Hydrus implant and phacoemulsification surgery, Hydrus implantation alone, or phacoemulsification alone as a control. The study collects "real world" data from up to 202 eyes treated at a center in Mainz, Germany. The focus includes evaluating IOP status over time, the need for additional IOP-lowering treatments, and safety outcomes related to these procedures. During the study, participants will have their eye pressure measured without medication washout after at least 8 years following surgery. Researchers will also assess the use of IOP-lowering medications, progression of visual field defects, and any additional surgical interventions required during follow-up. Subgroups, including those with bilateral implants, will be analyzed separately. The study's long-term observation helps provide a comprehensive view of the Hydrus implant's impact on glaucoma management over many years.
CONDITIONS
Brief Title
Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient participated in one of these trials at the Mainz clinical trial site: HYDRUS I, HYDRUS II, HYDRUS IV, or the retrospective SPECTRUM data collection
- Patient received either concomitant Hydrus implant and phacoemulsification, Hydrus implant alone, or phacoemulsification alone (control group)
- Patient has a minimum follow-up period of 8 years after surgery
- Patient is willing to participate and has signed informed consent
- Patient is able to give consent
You will not qualify if you...
- Participation in another interventional study or recent interventions with ongoing effects within the last 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 years
Participants who previously underwent Hydrus implant combined with phacoemulsification or related eye surgeries are observed to evaluate long-term effectiveness and safety over 8 years.
Periodic visits over 8 years
Trial Site Locations
Total: 1 location
1
Department of Opthalmology
Mainz, Rhineland-Palatinate, Germany, 55131
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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