Actively Recruiting
Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years
Led by Johannes Gutenberg University Mainz · Updated on 2026-03-10
200
Participants Needed
1
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the long-term effectiveness and safety of the Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP).Glaucoma patients often have high intraocular pressures (IOP) and need long-term IOP control to prevent loss of visual function and blindness. To date, data on the results of up to 5 years after Hydrus implantation have been published. However, to our knowledge, long-term data over a longer period of time are not yet available. The implementation of this study with a follow-up of the patients after ≥ 8 years (up to 14 years) represents the longest follow-up period to date with a cohort of up to 202 eyes in Mainz, Germany. It enables the collection of "real world data" ≥ 8 years after the Hydrus implantation and provides information about the current status of glaucoma and the effect of the Hydrus implant over this long period (including IOP status, IOP-lowering interventions that have taken place in the meantime, the status of the IOP-lowering medications used, ocular safety, quality of life etc.).
CONDITIONS
Official 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 the following trials at the Mainz clinical trial site: HYDRUS I, HYDRUS II, HYDRUS IV, or the retrospective SPECTRUM data collection
- Patient received either the Hydrus implant with phacoemulsification, the Hydrus implant alone, or phacoemulsification alone as a control
- Patient has a minimum follow-up period after surgery of 8 years at the study visit
- Willingness to participate in the study with signed and dated informed consent
- Ability to provide consent
You will not qualify if you...
- Simultaneous participation in another interventional study or recent interventions with ongoing effects within 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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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