Alcon Hydrus Stent Implantation - Long Term Follow up After 8 Years

NCT07460791 | Recruiting

• 2 other identifiers: 24-02116IIT#94592191
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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 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

Outcome Measures

Primary Outcomes (1)

• • 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 Outcomes (4)

• Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation 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

  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.

  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)

  8 years

Study Arms (2)

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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

You may not qualify if:

• \. Simultaneous participation in another interventional study or past interventions whose effect may still be ongoing (30 days)

Sponsors & Collaborators

• Johannes Gutenberg University Mainz: lead

Study Sites (1)

Department of Opthalmology

Mainz, Rhineland-Palatinate, 55131, Germany

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Dr

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 10, 2026
• Study Start: April 3, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: March 10, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)