Hydrus stent long-term follow-up after eight years
Official title: An Ambispective, Monocentric, Non-interventional Long-term Follow-up Trial to Evaluate the Effectiveness and Safety of the Hydrus Implant Combined With Concomitant Phacoemulsification for Lowering Intraocular Pressure (IOP) in Glaucoma Patients
Run by Johannes Gutenberg University Mainz · NCT07460791 · Data updated 2026-11-12
This follow-up will see if the Hydrus microstent continues to lower eye pressure and remains safe in people with glaucoma who had the implant at least eight years ago.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Johannes Gutenberg University Mainz Academic / other |
| Locations | 1 site (Mainz, Rhineland-Palatinate) |
| Status | Recruiting |
| Started | April 3, 2025 |
| Main results expected | August 31, 2026 |
| Study ends | August 31, 2026 |
| Registry record updated | March 10, 2026 |
| Trial ID | NCT07460791 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
People who previously received a Hydrus implant (with or without cataract surgery) as part of the listed Mainz trials or the SPECTRUM collection, have at least eight years of follow-up, and can provide informed consent.
✕Probably not a fit
Patients who never received a Hydrus implant, lack eight or more years of follow-up, or were treated at other centers are not eligible and would not gain direct information from this follow-up.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational follow-up will collect clinical data from patients in Mainz who received the Hydrus microstent with or without phacoemulsification at least eight years earlier. Researchers will record current intraocular pressure, any additional glaucoma procedures or medications, visual function, and device-related adverse events across a cohort of up to 202 eyes with 8–14 years of follow-up. No new interventions are planned; data will come from clinical exams and chart review to characterize real-world durability and long-term safety of the implant. Participants were originally enrolled in earlier Hydrus trials or a retrospective SPECTRUM collection at the Mainz site, and reconsent will be obtained for this extended follow-up.
Why it matters
Potential benefit: If results show sustained pressure lowering and acceptable safety, patients and clinicians could use this information to make better long-term treatment choices for glaucoma.
How similar studies have gone: Prior publications report Hydrus outcomes up to five years with favorable pressure reduction and safety, but follow-up beyond eight years is novel and limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1\. Patient participated in one of the following trials in the clinical trial site in Mainz: 1. the Ivantis, Inc. HYDRUS I trial (NCT03065036), 2. the Ivantis, Inc. HYDRUS II trial (NCT01818115), 3. the Ivantis, Inc. HYDRUS IV trial (NCT01539239), 4. or in the retrospective SPECTRUM data collection. 2. Patient received either concomitant implantation of the Hydrus implant and phacoemulsification or the Hydrus implant alone or participated in the control group (phacoemusification alone) 3. Patient has a minimum follow-up period after surgery of 8 years at the study visit 4. Willingness to participate in the study, the subject's signed and dated informed consent must be submitted before the start of the study 5. Ability of subject to give consent \- Exclusion Criteria: 1\. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days) \-
Where it's running
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Department of Opthalmology
Mainz, Rhineland-Palatinate, Germany Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.