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RECRUITING
NCT07460791

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

Sponsor: Johannes Gutenberg University Mainz

View on ClinicalTrials.gov

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.).

Official 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

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2025-04-03

Completion Date

2026-08-31

Last Updated

2026-03-10

Healthy Volunteers

No

Conditions

Locations (1)

Department of Opthalmology

Mainz, Rhineland-Palatinate, Germany