Hydrus stent long-term follow-up after eight years
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
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 |
|---|---|
| Enrollment | 200 (estimated) |
| Sex | All |
| Sponsor | Johannes Gutenberg University Mainz Academic / other |
| Locations | 1 site (Mainz, Rhineland-Palatinate) |
| Trial ID | NCT07460791 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Mainz, Rhineland-Palatinate
- Department of Opthalmology — Mainz, Rhineland-Palatinate, Germany (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.