An observational study in Glaucoma, sponsored by Johannes Gutenberg University Mainz. Recruiting at 1 site in Germany. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Johannes Gutenberg University Mainz · Observational
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.).
1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.
This study's planned enrollment of 200 is above the median of 101 across 385 observational studies indexed under Glaucoma.
Browse Glaucoma studies →Johannes Gutenberg University Mainz is the lead sponsor of 156 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
1. Patient participated in one of the following trials in the clinical trial site in Mainz:
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 must be submitted before the start of the study 5. Ability of subject to give consent
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Exclusion Criteria:
1. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 will be analyzed that received Hydrus implantation alone or phacoemulsification alone (control group) or Hydrus implantation in both eyes.
• 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
Time frame: 8 years
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
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
Rate of Progression of Mean defect (reduction of MD per year)
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.
Surgical interventions in the follow-up period will be recorded.
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)
subjects who received combined surgery in both eyes will be compared for efficacy and safety
Time frame: 8 years
Plan to share: No
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Aug 2026, 16 months after the start.
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No contact was published for this record. The registry link below has the sponsor’s details.
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Johannes Gutenberg University Mainz →