NCT07460791

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Johannes Gutenberg University Mainz · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Timeline

• Start date: 2025-04-03
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2026-03-10
• Last updated: 2026-03-10

Locations

1 site across 1 country: Germany