Skip to main content
OpenTrials
Recruiting

NCT Number: NCT07460791

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

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.).

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Opthalmology

Mainz, Rhineland-Palatinate, 55131, Germany

Location status: Recruiting

Location contact

Katrin Prof. Dr. Dr. Lorenz

CONTACT

[email protected]

+49 6131 17 7517

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

-

Exclusion criteria

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

-

Treatment and study plan

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

    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

Secondary outcomes

  1. Effect of IOP lowering medications in those Glaucoma patients whom underwent combined Hydrus stent implantation and Phacoemulsification.

    Time frame: 8 years

    • Medication counts during 8-years of follow-up up in glaucoma patients undergoing concomitant implantation of the Hydrus implant and phacoemulsification

  2. 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

    Rate of Progression of Mean defect (reduction of MD per year)

  3. 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

    Surgical interventions in the follow-up period will be recorded.

  4. 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

    subjects who received combined surgery in both eyes will be compared for efficacy and safety

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study 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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Mar 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.