NCT07460791Recruiting
Alcon Hydrus Stent Implantation - Long Term Follow up After 8 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
Source: ClinicalTrials.gov · Last updated 10 Mar 2026
Brief summary (registry, in English)
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.).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 19 Feb 2026
- Start date
- 3 Apr 2025
- Primary completion date
- 31 Aug 2026
- Lead sponsor
- Johannes Gutenberg University Mainz
- Diseases
- Glaucoma
- NCT number
- NCT07460791
What you commit to
- Study type: Observational
- Planned participants: 200
- From 3 Apr 2025 to the primary completion date, 31 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- 1\. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
- \-
Who the study is looking for
- 1\. Patient participated in one of the following trials in the clinical trial site in Mainz:
- the Ivantis, Inc. HYDRUS I trial (NCT03065036),
- the Ivantis, Inc. HYDRUS II trial (NCT01818115),
- the Ivantis, Inc. HYDRUS IV trial (NCT01539239),
- 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
- \-
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Department of Opthalmology Coordinator of this site? Confirm its status | Mainz | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.