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

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 Overview

• Status: Recruiting
• Conditions: Glaucoma

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, 55131
      • Recruiting
      • Department of Opthalmology
      • Contact: Katrin Prof. Dr. Dr. Lorenz; Phone Number: +49 6131 17 7517; Email: katrin.lorenz@unimedizin-mainz.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

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.

Description

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)

   -

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
• 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	8 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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)	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.	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	8 years

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 4, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): March 10, 2026
• Last Update Submitted That Met QC Criteria: March 4, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Glaucoma; Hydrus Stent; more than 8 years of follow up
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 24-02116; IIT#94592191 (Other Grant/Funding Number: Alcon Deutschland GmbH)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No