GlaucomaNCT07460791
Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years
An observational study of Glaucoma, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glaucoma
- How many people
- 200 participants
- Where
- 1 siteGermany
- Study dates
- 3 Apr 2025to 31 Aug 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Up to 202 eyes will be examined in this long-term follow-up trial. Patients from the Hydrus I, II, IV trials and the Spectrum Data Collection will be invited for participation in this trial.
Who may be able to join
- 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
- -
Who cannot join
- 1. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
- -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Opthalmology
Mainz, Rhineland-Palatinate, 55131
Katrin Prof. Dr. Dr. Lorenz, +49 6131 17 7517, katrin.lorenz@unimedizin-mainz.de
About this study
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
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
- Glaucoma
- Keywords
- Glaucoma, Hydrus Stent, more than 8 years of follow up
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| The subjects whom underwent Hydrus implant combined with phacoemulsification | The subjects whom underwent Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP), to evaluavte the long term effectiveness and safety. | |
| smaller subgroups as the control group,whom underwent not a combined surgery | smaller subgroups will be analyzed that received Hydrus implantation alone or phacoemulsification alone (control group) or Hydrus implantation in both eyes. |
What is being measured
The primary outcome is the main question the study is designed to answer.
• Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
- Assess the mean IOP(mmHg) after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
Measured: 8 years
Secondary outcomes (4)
Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation and Phacoemulsification.
- Medication counts during 8-years of follow-up up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
Measured: 8 years
Rate of Progression of Mean defect in visual field examination in Glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
Rate of Progression of Mean defect (reduction of MD per year)
Measured: 8 years
Numbers of IOP lowering secondary surgical interventions during 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification.
Surgical interventions in the follow-up period will be recorded.
Measured: 8 years
Differentiation of IOP reduction and safety between eyes of the patients after 8-years of follow-up (in subjects who received the Hydrus implant in both eyes)
subjects who received combined surgery in both eyes will be compared for efficacy and safety
Measured: 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start3 Apr 2025
- Primary completion31 Aug 2026 (estimated)
- Study completion31 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katrin Lorenz, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07460791
- Sponsor's protocol ID
- 24-02116
- Other IDs
- IIT#94592191
- Status last verified
- Feb 2026
- First submitted
- 19 Feb 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07460791
- Acronym / sponsor ID
- 24-02116
- Conditions
- Glaucoma
- Keywords
- Glaucoma, Hydrus Stent, more than 8 years of follow up
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 3 Apr 2025 (actual)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 31 Aug 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The subjects whom underwent Hydrus implant combined with phacoemulsification | – | –The subjects whom underwent Hydrus implant combined with concomitant phacoemulsification for lowering intraocular pressure (IOP), to evaluavte the long term effectiveness and safety. |
| smaller subgroups as the control group,whom underwent not a combined surgery | – | –smaller subgroups will be analyzed that received Hydrus implantation alone or phacoemulsification alone (control group) or Hydrus implantation in both eyes. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Up to 202 eyes will be examined in this long-term follow-up trial. Patients from the Hydrus I, II, IV trials and the Spectrum Data Collection will be invited for participation in this trial.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (2 listed)
- 1. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
• Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
Time frame: 8 years
• Assess the mean IOP(mmHg) after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
4 secondary outcomes
Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation and Phacoemulsification.
Time frame: 8 years
Rate of Progression of Mean defect in visual field examination in Glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification
Time frame: 8 years
Numbers of IOP lowering secondary surgical interventions during 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification.
Time frame: 8 years
Differentiation of IOP reduction and safety between eyes of the patients after 8-years of follow-up (in subjects who received the Hydrus implant in both eyes)
Time frame: 8 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glaucoma, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
• Mean non washed out IOP (mmHg) reduction after 8 years of follow-up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification (time frame: 8 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2026.